Surgical staple having an expandable portion

ABSTRACT

A surgical staple including features which can reduce bleeding from soft tissue. In various embodiments, the surgical staple can include at least one deformable member which can puncture a hole in soft tissue as it is inserted therethrough. The deformable member can include a material thereon, or can be comprised of a material, which can expand and substantially fill the puncture hole in the soft tissue. In various embodiments, at least a portion of the deformable member can be coated with a hydrophilic material which can expand when exposed to water, or other bodily fluids, and apply a compression force to the perimeter of the puncture hole. Such a compression force can reduce bleeding from the puncture hole and thereby reduce any potential complications resulting therefrom.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional application, under 35 U.S.C. §121, ofU.S. patent application Ser. No. 11/824,446, filed Jun. 29, 2007,entitled SURGICAL STAPLE HAVING AN EXPANDABLE PORTION, now United StatesPatent Publication Number 2009/0001121, the entire disclosure of whichis incorporated by reference herein.

BACKGROUND

The present application is related to the following commonly-owned U.S.patent applications, which are hereby incorporated by reference in theirentirety: (1)

U.S. patent application Ser. No. 11/824,389, filed on Jun. 29, 2007, nowU.S. Pat. No. 7,669,747, entitled WASHER FOR USE WITH A SURGICALSTAPLING INSTRUMENT;

(2) U.S. patent application Ser. No. 11/824,251, filed on Jun. 29, 2007,now U.S. Patent Publication No. 2009/0005807, entitled SURGICAL STAPLEHAVING A SLIDABLE CROWN;

(3) U.S. patent application Ser. No. 11/824,363, filed on Jun. 29, 2007,now U.S. Patent Publication No. 2008/0082115, entitled METHOD OFMANUFACTURING STAPLES;

(4) U.S. patent application Ser. No. 11/824,415, filed Jun. 29, 2007,now U.S. Pat. No. 7,604,151, entitled SURGICAL STAPLES WITH IMPROVEDTISSUE COMPRESSION FEATURES;

(5) U.S. patent application Ser. No. 11/824,274, filed Jun. 29, 2007,now U.S. Patent Publication No. 2009/0001124, entitled STAPLE CARTRIDGECAVITY CONFIGURATIONS;

(6) U.S. patent application Ser. No. 11/824,275, filed Jun. 29, 2007,now U.S. Patent Publication No. 2009/0005808, entitled STAPLE CARTRIDGECAVITY CONFIGURATION WITH COOPERATIVE SURGICAL STAPLE;

(7) U.S. patent application Ser. No. 11/823,988, filed Jun. 29, 2007,now U.S. Patent Publication No. 2009/0005809, entitled SURGICAL STAPLEHAVING A SLIDABLE CROWN;

(8) U.S. patent application Ser. No. 11/824,079, filed Jun. 29, 2007,now U.S. Pat. No. 7,438,209, entitled SURGICAL STAPLING INSTRUMENTSHAVING A RELEASABLE STAPLE-FORMING POCKET;

(9) U.S. patent application Ser. No. 11/824,524, filed Jun. 29, 2007,now U.S. Patent Publication No. 2009/0001130, entitled SURGICALPROCEDURE USING A CUTTING AND STAPLING INSTRUMENT HAVING RELEASABLESTAPLE-FORMING POCKETS;

(10) U.S. patent application Ser. No. 11/824,299, filed Jun. 29, 2007,now U.S. Patent Publication No. 2008/0082125, entitled SURGICAL STAPLEHAVING A DEFORMABLE MEMBER WITH A NON-CIRCULAR CROSS-SECTIONAL GEOMETRY;

(11) U.S. patent application Ser. No. 11/824,136, filed Jun. 29, 2007,now U.S. Patent Publication No. 2008/0082126, entitled SURGICAL STAPLEHAVING A DEFORMABLE MEMBER WITH A NON-CIRCULAR CROSS-SECTIONAL GEOMETRY;

(12) U.S. patent application Ser. No. 11/824,298, filed Jun. 29, 2007,now U.S. Pat. No. 7,673,782, entitled SURGICAL STAPLING INSTRUMENTHAVING A RELEASABLE BUTTRESS MATERIAL; and

(13) U.S. patent application Ser. No. 11/824,252, filed Jun. 29, 2007,now U.S. Pat. No. 7,735,703, entitled RE-LOADABLE SURGICAL STAPLINGINSTRUMENT.

FIELD OF THE INVENTION

The present invention generally relates to surgical instruments and,more particularly, to surgical stapling instruments and staples for usetherewith.

DESCRIPTION OF RELATED ART

Surgical staplers can be used during a variety of surgical techniques.During at least one surgical technique, a surgical stapler can beinserted through a cannula, or tube, positioned within a small incisionin a patient's body. These surgical techniques are referred to asendoscopic and/or laparoscopic surgical techniques and are oftenpreferred over traditional, or open, surgical techniques as they canreduce the recovery time of the patient. Surgical staplers used duringsuch techniques often include an end effector which can be used toachieve a variety of diagnostic and/or therapeutic effects. In variousembodiments, such surgical staplers can include an end effector that canincise soft tissue and insert staples into the soft tissue on opposingsides of the incision. In at least one embodiment, the end effector caninclude a pair of cooperating jaw members that can be passed through thecannula where one of the jaw members can include a staple cartridge andthe other jaw member can include an anvil. In at least one suchembodiment, the staple cartridge can be configured to deploy at leasttwo rows of staples into the tissue and the anvil can includestaple-forming pockets which can be configured to deform the staples asthey are deployed.

Some surgical staplers, such as those described in U.S. Pat. No.5,465,895, entitled SURGICAL STAPLER INSTRUMENT, issued on Nov. 14,1995, the disclosure of which is hereby incorporated by referenceherein, can include an end effector having a cutting member and stapledriver, for example, where the cutting member and staple driver can bemoved along a linear, curved, and/or curvilinear path within the endeffector. Such surgical staplers are often referred to as endocuttersand can be utilized during gastric bypass surgical techniques in whichthe size of a patient's stomach can be reduced, for example. One of themost common gastric bypass surgical techniques is a Roux-en-Y gastricbypass. In such a technique, the stomach can be transected into at leasttwo portions where one of the portions can be formed into a small pouchwhich can be connected directly to a middle portion of the patient'ssmall intestine, i.e., the jejunum. In various circumstances, theendocutter can be used to cut the stomach along a desired path anddeploy staples into the stomach tissue in order to hold the stomachtissue together. As a result of the above-described technique, foodpassing through the digestive tract can bypass the other transectedportion of the stomach and an upper portion of the small intestine,i.e., the duodenum.

Other surgical staplers, such as intra-luminal, or circular, staplers,for example, have been developed to assist a surgeon during a surgicaltechnique known as an anastomosis. An anastomosis is a surgicaltechnique in which a small and/or large intestine is transected, aportion thereof is excised, and the remaining portions are joinedtogether. This technique often requires a surgeon to transect the smallintestine, for example, at two locations creating a first end, a secondend, and an intermediate portion. Thereafter, the intermediate portioncan be removed and the first and second ends can be positioned adjacentto each other. In order to join the first and second ends, the first andsecond ends can be positioned within an intra-luminal, or circular,stapler such that staples can be deployed into the first and second endsaround the perimeter thereof to hold the first and second ends together.Such staplers are disclosed in U.S. Pat. No. 5,104,025, entitledINTRALUMINAL ANASTOMOTIC SURGICAL STAPLER WITH DETACHED ANVIL, issued onApr. 14, 1992, and U.S. Pat. No. 5,309,927, entitled CIRCULAR STAPLERTISSUE RETENTION SPRING METHOD, issued on May 10, 1994, the disclosuresof which are hereby incorporated by reference herein.

SUMMARY OF THE INVENTION

In various forms of the invention, an end effector of a surgical staplercan include an anvil and a staple cartridge where the staple cartridgecan be configured to removably store staples therein. In variousembodiments, the staple cartridge can include cavities configured tostore the staples until they are deployed therefrom by a staple driverwhich can be configured to traverse the staple cartridge and move thestaples toward the anvil. In at least one embodiment, the staples caneach include at least one deformable member which can be deformed whenit contacts the anvil such that the deformable member can capture softtissue, for example, between a crown of the staple and the deformablemember. In at least one form of the invention, the deformable member caninclude a non-circular cross-section which can, in various embodiments,dictate the direction and manner in which the deformable member is bent.In at least one embodiment, the non-circular cross-section can include aflat portion which can cause the deformable member to bend in thedirection of the flat portion. In various embodiments, the non-circularportion of the cross-section can be configured to abut the soft tissueand apply a compressive force or pressure thereto. In at least one suchembodiment, the crown of the surgical staple can be at least partiallycomprised of a dissolvable or bioabsorbable material such that the crowncan dissolve as the soft tissue heals and can, depending on thecross-sectional geometry of the deformable member, reduce the force orpressure applied to the soft tissue by the deformable member.

In at least one form of the invention, a surgical staple can include adeformable member and a crown, wherein the deformable member can be slidrelative to the crown. In at least one embodiment, a staple cartridgecan include a cavity and a deck, where the cavity can be configured toreceive at least a portion of the deformable member and the crown can bepositioned within an opening in the deck. In various embodiments, whensoft tissue is captured between the anvil and the staple cartridge, thecrown can apply a compressive force or pressure to the soft tissue evenbefore the deformable member is deployed toward the anvil by the stapledriver. In at least one such embodiment, as a result, the purchaseand/or compressive force, or pressure, between the surgical staple andthe soft tissue can be improved. In various embodiments, the crowns oftwo or more adjacent staples can be connected. In at least one suchembodiment, the crowns can apply a uniform pressure to the soft tissueand, in various circumstances, increase the stiffness of the soft tissueafter the staples have been deployed therein.

In various forms of the invention, surgical staples can be deployed intosoft tissue, for example, in order to reduce, or eliminate, bleedingtherefrom especially after the soft tissue has been incised. In variousembodiments, the staples can be arranged within a staple cartridge suchthat they are deployed into the soft tissue in at least two rows, orlines, in order to constrict blood vessels in the soft tissue. In atleast one embodiment, a staple cartridge can include first and secondstaple cavities therein where the first cavity can define a first axis,the second cavity can define a second axis, and the first axis can betransverse to the second axis. In at least one such embodiment, thefirst and second cavities can extend in directions which are notparallel to each other and, owing to the arrangement of the staplespositioned therein, the staples can better constrict the blood vesselsin the soft tissue and reduce the flow of blood therethrough. In variousforms of the invention, surgical staples can include features which cancooperate with staple cavities in a staple cartridge in order to reduce,or even prevent, the staples from rocking, or tilting, within the staplecavities when the staples are deployed by a staple driver, for example,especially when the staples are oriented in different directions. In atleast one such embodiment, the crowns of the staples can include arcuateand/or cylindrical features which can cooperate with arcuate and/orcylindrical features of the staple cavities in order to reduce unwantedrelative movement, or rotation, between the staples and the staplecavities.

In various forms of the invention, a surgical staple can includefeatures which can further reduce bleeding from the soft tissue, forexample. In at least one embodiment, the staple can include at least onedeformable member which can puncture a hole in the soft tissue as it isinserted therethrough and, in various embodiments, the deformable membercan include a material thereon, or can be comprised of a material, whichcan expand and substantially fill the puncture hole in the soft tissue.In various embodiments, at least a portion of the deformable member canbe coated with a hydrophilic material, for example, which can expandwhen exposed to water, or other fluids in the body, and apply acompression force to the perimeter of the puncture hole. Such acompression force can reduce bleeding from the puncture hole and therebyreduce any potential complications resulting therefrom. In at least oneform of the invention, a crown of the surgical staple can includefeatures surrounding, or positioned adjacent to, the deformable memberswhich can compress the soft tissue surrounding the deformable membersand increase the compressive force or pressure applied thereto. As aresult of the increased compressive force or pressure, the flow of bloodfrom the puncture holes created by the deformable members can bereduced.

In various forms of the invention, a surgical stapler can include ananvil, a staple cartridge, and a buttress material removably retained tothe anvil and/or staple cartridge. In various embodiments, the staplecartridge can include at least one staple removably stored therein whichcan, when deployed, or fired, therefrom, contact the buttress materialand remove the buttress material from the anvil and/or staple cartridge.In at least one embodiment, the anvil can include at least one lipand/or groove configured to removably retain the buttress material tothe anvil until deformable members extending from the surgical staple,for example, are bent by the anvil and are directed toward and contactthe buttress material. In various embodiments, the buttress material canbe configured to stiffen the soft tissue and/or at least inhibit thestaples from tearing the soft tissue. In at least one form of theinvention, the anvil of the surgical stapler can include releasablepocket elements that can capture the ends of the deployed, or fired,staples. In various embodiments, the pocket elements can be releasedfrom the anvil such that the pocket elements remain with the staples andthe stapled tissue after the stapler has been fired. When deployed, theends of the staples may be turned, or bent, by the pocket elements inthe anvil and, thereafter, the ends of the staples may contact astaple-end retaining surface of the pocket element that prevents theends of the staples from re-puncturing or otherwise re-penetrating thesoft tissue. In at least one embodiment, the forces created during thestapling and/or cutting actions of the stapler can overcome apressure-fit force retaining the pocket elements in the anvil such thatthe pocket elements are released upon firing. The releasable pocketelements may be made from the same material as the crowns of the stapleswhich can be comprised of, for example, a bioabsorbable material and/ora non-bioabsorbable material.

In yet another general aspect, various forms of the present inventionare directed to surgical procedures, such as Roux-en-Y gastric bypassprocedures or other procedures, using staples and stapling devicesdescribed herein. In particular, various surgical procedures can beperformed where a band is placed around soft tissue, for example, thathas been incised and stapled. In such techniques, staples and/orstapling devices can be used where the staple ends are not exposed afterbeing inserted into the soft tissue such that the staple ends do notsnag or otherwise damage the band which can, in various circumstances,irritate the soft tissue. For example, an instrument having thereleasable pocket elements described above may be used to staple thetissue in the area where the band is to be placed. The releasable pocketelements, once released from the anvil, may protect the soft tissue andthe band from the staple ends. In various circumstances, a cliniciancould use two instruments for such a procedure: one not havingreleasable pocket elements for incisions that are made in areas of thesoft tissue where the band will not be placed; and another instrumenthaving releasable pocket elements for incisions that are made in thearea of the soft tissue where the band is to be placed. In otherembodiments, the clinician could use one instrument and selectively loadthe instrument with an anvil having the releasable pocket elements forthe incisions that are to be made in the area of the soft tissue wherethe band is to be placed.

In yet another aspect, various forms of the invention are directed to astapler having a so-called “breakaway” washer inserted into the anvil.In various embodiments, the washer can include a circular outer portionand a circular inner portion. In at least one such embodiment, the outerportion may include a number of staple guide sections that defineopenings through which the staple ends of surgical staples are drivenwhen the instrument is fired and are thereafter bent, or turned, by theanvil. After being turned, the staple ends may contact and may beretained by the staple guide sections so that the staple ends do notre-penetrate or otherwise re-puncture the stapled tissue. In variousembodiments, the surgical instrument may further include a knife whichcan cut the washer when the surgical instrument is fired so that theinner portion is separated from the outer portion and, as a result, theouter portion can remain with the staples after they have been firedinto the soft tissue. As a result, the outer portion of the washer mayprovide a fixed staple line, which may be particularly beneficial forcertain types of anastomotic procedures. In various embodiments, thewasher can be made of a non-bioabsorbable material although, in otherembodiments, the washer can be made of a bioabsorbable material.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of this invention,and the manner of attaining them, will become more apparent and theinvention itself will be better understood by reference to the followingdescription of embodiments of the invention taken in conjunction withthe accompanying drawings, wherein:

FIG. 1 is a perspective view of a surgical instrument in accordance withone non-limiting embodiment of the present invention;

FIG. 2 is a perspective view of the surgical instrument of FIG. 1;

FIG. 3 is an exploded view of an end effector of the surgical instrumentof FIG. 1;

FIG. 4 is a perspective view of the surgical instrument of FIG. 1 beingused to incise and staple soft tissue;

FIG. 5 is an elevational view of a surgical staple in an undeformedshape;

FIG. 6 is an elevational view of the staple of FIG. 5 in a firstdeformed shape;

FIG. 7 is an elevational view of the staple of FIG. 5 in a seconddeformed shape;

FIG. 8 is an elevational view of the staple of FIG. 5 in a thirddeformed shape;

FIG. 9 is a top view of the staple of FIG. 5 in the third deformed shapeof FIG. 8;

FIG. 10 is a partial cross-sectional view of the surgical stapler ofFIG. 1 being used to deploy the surgical staples of FIG. 5 into softtissue;

FIG. 10A is an elevational view of a surgical staple in a partiallydeformed shape;

FIG. 11 is a perspective view of first and second deformable members ofa surgical staple;

FIG. 12 is a perspective view of a dissolvable, or bioabsorbable,material overmolded onto the deformable members of FIG. 12;

FIG. 13 is a perspective view of the staple of FIG. 12 in a deformedshape;

FIG. 14 is a perspective view of the staple of FIG. 12 where a portionof the dissolvable material has been dissolved and the first and seconddeformable members have moved relative to one another;

FIG. 15 is a perspective view of the staple of FIG. 12 after thedissolvable material has completely dissolved;

FIG. 16 is a partial cross-sectional view of a surgical stapler beingused to deploy the surgical staples of FIG. 12 into soft tissue;

FIG. 17 is an additional partial cross-sectional view of the surgicalstapler of FIG. 16;

FIG. 18 is a perspective view of a deformable member of a staple inaccordance with one non-limiting embodiment of the present invention;

FIG. 19 is a top view of the deformable member of FIG. 18;

FIG. 20 is a perspective view of a dissolvable, or bioabsorbable,material overmolded onto the deformable member of FIG. 18 in accordancewith one non-limiting embodiment of the present invention;

FIG. 21 is a perspective view of first and second deformable members ofa staple in accordance with one non-limiting embodiment of the presentinvention;

FIG. 22 is a top view of the deformable members of FIG. 21;

FIG. 23 is a perspective view of a dissolvable, or bioabsorbable,material overmolded onto the deformable members of FIG. 21 in accordancewith one non-limiting embodiment of the present invention;

FIG. 24 is a perspective view of the staple of FIG. 23 in a deformedshape;

FIG. 25 is a perspective view of the staple of FIG. 23 wherein a portionof the dissolvable material has been dissolved and the first and seconddeformable members have moved relative to one another;

FIG. 26 is a perspective view of the staple of FIG. 24 after thedissolvable or bioabsorbable material has completely dissolved;

FIG. 27 is a perspective view of first and second deformable membershaving an expandable coating formed thereon in accordance with onenon-limiting embodiment of the present invention;

FIG. 28 is a top view of the deformable members of FIG. 27;

FIG. 29 is a perspective view of a dissolvable, or bioabsorbable,material overmolded onto the first and second deformable members of FIG.27 in accordance with one non-limiting embodiment of the presentinvention;

FIG. 30 is a perspective view of the staple of FIG. 29 in a deformedconfiguration;

FIG. 31 is a perspective view of the staple of FIG. 29 after at least aportion of the dissolvable material has dissolved and the expandablematerial has expanded;

FIG. 32 is a top view of the staple of FIG. 29 illustrating theexpandable coating in an expanded form;

FIG. 33 is a perspective view of the staple of FIG. 29 after thedissolvable material and the expandable material has completelydissolved;

FIG. 34 is a perspective view of an end portion of a deformable memberin accordance with one non-limiting embodiment of the present invention;

FIG. 35 is a cross-sectional view of the deformable member of FIG. 34;

FIG. 36 is a perspective view of an end portion of another deformablemember in accordance with one non-limiting embodiment of the presentinvention;

FIG. 37 is a cross-sectional view of the deformable member of FIG. 36;

FIG. 38 is a perspective view of an end portion of another deformablemember in accordance with one non-limiting embodiment of the presentinvention;

FIG. 39 is a cross-sectional view of the deformable member of FIG. 38;

FIG. 40 is a perspective view of an end portion of another deformablemember in accordance with one non-limiting embodiment of the presentinvention;

FIG. 41 is a cross-sectional view of the deformable member of FIG. 40;

FIG. 42 is a perspective view of an end portion of another deformablemember in accordance with one non-limiting embodiment of the presentinvention;

FIG. 43 is a cross-sectional view of the deformable member of FIG. 42;

FIG. 44 is a perspective view of an end portion of another deformablemember in accordance with one non-limiting embodiment of the presentinvention;

FIG. 45 is a cross-sectional view of the deformable member of FIG. 44;

FIG. 46 is a perspective view of an end portion of another deformablemember in accordance with one non-limiting embodiment of the presentinvention;

FIG. 47 is a cross-sectional view of the deformable member of FIG. 46;

FIG. 48 is a perspective view of an end portion of another deformablemember in accordance with one non-limiting embodiment of the presentinvention;

FIG. 49 is a cross-sectional view of the deformable member of FIG. 48;

FIG. 50 is a perspective view of an end portion of another deformablemember in accordance with one non-limiting embodiment of the presentinvention;

FIG. 51 is a cross-sectional view of the deformable member of FIG. 50;

FIG. 52 is a perspective view of an end portion of another deformablemember in accordance with one non-limiting embodiment of the presentinvention;

FIG. 53 is a cross-sectional view of the deformable member of FIG. 52;

FIG. 54 is a perspective view of an end portion of another deformablemember in accordance with one non-limiting embodiment of the presentinvention;

FIG. 55 is a cross-sectional view of the deformable member of FIG. 54;

FIG. 56 is a perspective view of an end portion of another deformablemember in accordance with one non-limiting embodiment of the presentinvention;

FIG. 57 is a cross-sectional view of the deformable member of FIG. 56;

FIG. 58 is an elevational view of a surgical staple having a slidablecrown in accordance with one non-limiting embodiment of the presentinvention;

FIG. 59 is an elevational view of another surgical staple having aslidable crown in accordance with one non-limiting embodiment of thepresent invention;

FIG. 60 is an elevational view of another surgical staple having aslidable crown in accordance with one non-limiting embodiment of thepresent invention;

FIG. 61 is a bottom view of the surgical staple of FIG. 58;

FIG. 62 is a bottom view of the surgical staple of FIG. 59;

FIG. 63 is a bottom view of the surgical staple of FIG. 60;

FIG. 64 is a top view of the surgical staple of FIG. 58;

FIG. 65 is a top view of the surgical staple of FIG. 59;

FIG. 66 is a top view of the surgical staple of FIG. 60;

FIG. 67 is a perspective cross-sectional view of a non-deployed surgicalstaple of FIG. 58 positioned within a staple cartridge in accordancewith one non-limiting embodiment of the present invention;

FIG. 68 is a perspective cross-sectional view of the staple of FIG. 67in a partially deployed position;

FIG. 69 is a perspective cross-sectional view of the staple of FIG. 67in a fully deployed position;

FIG. 70 is a perspective view of the staple of FIG. 67 in a fullydeployed position;

FIG. 71 is perspective view of the staple cartridge of FIG. 67illustrating several surgical staples in an undeployed position;

FIG. 72 is a perspective view of an assembly of a plurality of thestaples of FIG. 58 connected by bridges in accordance with onenon-limiting embodiment of the present invention;

FIG. 73 is another perspective view of the assembly of FIG. 72;

FIG. 74 is a top view of a staple cartridge with the assembly of FIG. 72situated therein in accordance with one non-limiting embodiment of thepresent invention;

FIG. 75 is a partial perspective view of the staple cartridge of FIG.74;

FIG. 76 is a top view of a staple cartridge and staple assemblies inaccordance with one non-limiting embodiment of the present invention;

FIG. 77 is an elevational view of a staple having a slidable crown andprojections extending therefrom in accordance with one non-limitingembodiment of the present invention;

FIG. 78 is an elevational view of the staple of FIG. 77 in a deployedposition;

FIG. 79 is a top view of the staple of FIG. 77;

FIG. 80 is a perspective view of several assemblies of the surgicalstaples of FIG. 77 connected by bridges in accordance with onenon-limiting embodiment of the present invention;

FIG. 81 is a partial perspective view of the assemblies of FIG. 80positioned within a staple cartridge in accordance with one non-limitingembodiment of the present invention;

FIG. 82 is a perspective cross-sectional view of the staple cartridge ofFIG. 81 with the staple assemblies in an undeployed position;

FIG. 83 is a perspective cross-sectional view of the staple cartridge ofFIG. 81 with the staple assemblies in a deployed position;

FIG. 84 is cross-sectional view of a surgical stapler deploying thestaples of FIG. 77;

FIG. 85 is a plan view of an elongate member used to form staples inaccordance with one non-limiting embodiment of the present invention;

FIG. 86 is a plan view of the elongate member of FIG. 85 illustratingcrowns overmolded onto the bases of the staples having connectionsegments interconnecting the crowns;

FIG. 87 is a plan view of the elongate member of FIG. 85 illustratingthe connection segments removed;

FIG. 88 is a plan view of the elongate member of FIG. 86 that has beencut along an axis;

FIG. 89 is a plan view of an alternate elongate member in accordancewith one non-limiting embodiment of the present invention;

FIG. 90 is a plan view of a deformable member that has been singulatedfrom the elongate member of FIG. 89 in accordance with one non-limitingembodiment of the present invention;

FIG. 91 is a plan view of another alternate elongate member inaccordance with one non-limiting embodiment of the present invention;

FIG. 92 is a plan view of the alternate elongate member of FIG. 91illustrating crowns overmolded on to the bases of the staples inaccordance with one non-limiting embodiment of the present invention;

FIG. 93 is a plan view of the elongate member of FIG. 92 after theelongate member has been cut along an axis;

FIGS. 94-99 are plan views of various alternate deformable members inaccordance with non-limiting embodiments of the present invention;

FIG. 100 is a side view of a singulated staple manufactured from theelongate member of FIG. 85 in accordance with one non-limitingembodiment of the present invention;

FIG. 101 is an elevational view of the staple of FIG. 100;

FIG. 102 is a perspective view of the staple of FIG. 100;

FIG. 103 is a perspective view of a transfer block in a closedconfiguration for molding a plurality of individual staples inaccordance with one non-limiting embodiment of the present invention;

FIG. 104 is a perspective view the transfer block of FIG. 103 in an openconfiguration for molding a plurality of individual staples inaccordance with one non-limiting embodiment of the present invention;

FIG. 105 is a plan view of an alternate transfer block in accordancewith one non-limiting embodiment of the present invention;

FIG. 106 is a plan view of another alternate transfer block inaccordance with one non-limiting embodiment of the present invention;

FIG. 107 is a perspective view of a staple cartridge in accordance withone non-limiting embodiment of the present invention;

FIG. 108 is a top view of the staple cartridge of FIG. 107;

FIG. 109 is a detail view of the staple cartridge of FIG. 107;

FIG. 110 is an additional detail view of the staple cartridge of FIG.107;

FIG. 110A is a detail view of a staple cartridge in accordance with onenon-limiting embodiment of the present invention;

FIG. 111 is a perspective view of a surgical staple configured to bepositioned within a staple cavity of the staple cartridge of FIG. 107;

FIG. 112 is a plan view of the surgical staple of FIG. 111;

FIG. 113 is a plan view of a staple cavity of a staple cartridge inaccordance with one non-limiting embodiment of the present invention;

FIG. 114 is a plan view of a staple cavity of a staple cartridge inaccordance with one non-limiting embodiment of the present invention;

FIG. 115 is a plan view of a staple cavity of a staple cartridge inaccordance with one non-limiting embodiment of the present invention;

FIG. 116 is a plan view of a staple cavity of a staple cartridge inaccordance with one non-limiting embodiment of the present invention;

FIG. 117 is a top view of a staple pattern along an incision, thepattern having substantially parallel rows of staples;

FIG. 118 is a top view of a staple cartridge having a staple pattern inaccordance with one non-limiting embodiment of the present invention;

FIG. 119 is a perspective view of the staple cartridge of FIG. 118;

FIG. 120 is a partial plan view of a staple cartridge having a staplepattern in accordance with one alternate embodiment of the presentinvention;

FIG. 121 is a partial top view of a staple cartridge having a staplepattern in accordance with another alternate embodiment of the presentinvention;

FIG. 122 is a perspective view of portions of an anvil, a staplecartridge, and a buttress material removably retained to the anvil inaccordance with one non-limiting embodiment of the present invention;

FIG. 123 is a cross-sectional view of the anvil and the buttressmaterial of FIG. 122;

FIG. 124 is a cross-sectional view of an anvil and a buttress materialin accordance with one alternate non-limiting embodiment of the presentinvention;

FIG. 125 is a cross-sectional view of the anvil, staple cartridge andbuttress material of the embodiment of FIG. 122 positioned relative tosoft tissue and surgical staples in an undeployed position;

FIG. 126 is an additional cross-sectional view of the embodiment of FIG.125 illustrating the staples in a deployed position;

FIG. 127 is an additional cross-sectional view of the embodiment of FIG.125 illustrating the anvil in an open position;

FIG. 128 is a diagram illustrating a stomach and a small intestine aftera Roux-en-Y gastric bypass surgical technique has been performedthereon;

FIG. 129 is a flow chart illustrating the steps of a gastric bypasssurgical technique in accordance with one non-limiting embodiment of thepresent invention;

FIG. 130 is a cross-sectional view of an anvil having portions thereofwhich can be broken away by a surgical staple in accordance with onenon-limiting embodiment of the present invention;

FIG. 131 is an additional view of the embodiment of FIG. 130illustrating surgical staples in a deployed configuration;

FIG. 132 is a cross-sectional view of an anvil having portions thereofwhich can be broken away by a surgical staple in accordance with onealternate non-limiting embodiment of the present invention;

FIG. 133 is an additional view of the embodiment of FIG. 120illustrating surgical staples in a deployed configuration;

FIG. 134 is a perspective view of a circular surgical staplinginstrument in accordance with one non-limiting embodiment of the presentinvention;

FIG. 135 is a partial perspective view of the stapling instrument ofFIG. 134 with portions of the stapling instrument removed;

FIG. 136 is an exploded view of the stapling instrument of FIG. 134;

FIG. 137 is an exploded view of an anvil and a ‘break-away’ washer ofthe surgical instrument of FIG. 134;

FIG. 138 is an assembly view of the anvil and the washer of FIG. 137;

FIG. 139 is a plan view of the assembly of FIG. 138;

FIG. 140 is a perspective view of an anvil member of a circular staplerin accordance with one non-limiting embodiment of the present invention;

FIG. 141 is a perspective view of a staple cartridge mechanism of acircular stapler in accordance with one non-limiting embodiment of thepresent invention;

FIG. 142 is a perspective view of the staple cartridge mechanism of FIG.141 assembled to the anvil member of FIG. 140 in accordance with onenon-limiting embodiment of the present invention;

FIG. 143 is a perspective view of an anvil member of a circular staplerin accordance with one alternate non-limiting embodiment of the presentinvention;

FIG. 144 is a perspective view of a staple cartridge mechanism of acircular stapler in accordance with one alternate non-limitingembodiment of the present invention;

FIG. 145 is a perspective view of view of the staple cartridge mechanismof FIG. 143 assembled to the anvil member of FIG. 144 in accordance withone non-limiting embodiment of the present invention;

FIG. 146 is a perspective view of an anvil member of a circular staplerin accordance with another alternate non-limiting embodiment of thepresent invention;

FIG. 147 is a perspective view of a staple cartridge mechanism of acircular stapler in accordance with another alternate non-limitingembodiment of the present invention; and

FIG. 148 is a perspective view of the staple cartridge mechanism of FIG.146 assembled to the anvil member of FIG. 147 in accordance with onenon-limiting embodiment of the present invention.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate preferred embodiments of the invention, in one form, and suchexemplifications are not to be construed as limiting the scope of theinvention in any manner.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those of ordinary skill in the art will understand that thedevices and methods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the various embodiments of the present invention is definedsolely by the claims. The features illustrated or described inconnection with one exemplary embodiment may be combined with thefeatures of other embodiments. Such modifications and variations areintended to be included within the scope of the present invention. FIGS.1 and 2 depict one embodiment of a surgical stapling and severinginstrument, i.e., endocutter 30, which is capable of practicing theunique benefits of the present invention. It should be recognized,however, that the unique and novel aspects of the present invention maybe advantageously employed in connection with a variety of otherstaplers and stapling instruments without departing from the spirit andscope of the present invention. Accordingly, the scope of protectionafforded to the various embodiments of the present invention should notbe limited to use only with the specific types of surgical stapling andsevering instruments described herein.

Referring to FIGS. 1 and 2, surgical instrument 30 can comprise handle32, shaft 34, and articulating end effector 36 pivotally connected toshaft 34 at articulation pivot 38. The placement and orientation of endeffector 36 may be facilitated by controls on handle 32, including (a)rotation knob 40 for rotating shaft 34 and end effector 36 about anaxis, and (b) articulation control 44 for effecting the rotation, orarticulation, of end effector 36 with respect to shaft 34 aboutarticulation pivot 38 as described in greater detail in commonly-owned,co-pending U.S. patent application Ser. No. 11/329,020, entitledSURGICAL INSTRUMENT HAVING AN ARTICULATING END EFFECTOR, which was filedon Jan. 10, 2006, the disclosure of which is incorporated by referenceherein. In various embodiments, handle 32 of instrument 30 may includeclosure trigger 46 and firing trigger 48 for actuating end effector 36as described in greater detail below. It will be appreciated, however,that instruments having end effectors configured to perform differentsurgical tasks may have different numbers or types of triggers or othersuitable controls for operating end effector 36. Furthermore, it will beappreciated that the terms “proximal” and “distal” are used herein withreference to a clinician gripping handle 32 of instrument 30. Thus, endeffector 36 is distal with respect to handle 32. [0015] In theillustrated embodiment, end effector 36 can be configured to clamp,sever, and staple soft tissue, for example. In other embodiments,different types of end effectors may be used such as graspers, cutters,staplers, clip appliers, access devices, drug/gene therapy devices,ultrasound, RF and/or laser devices, for example. End effector 36 caninclude, among other things, staple channel 50 and a translatableclamping member, such as anvil 52, for example, where staple channel 50and anvil 52 can be relatively positioned, or spaced, in order to assurethat soft tissue clamped in end effector 36 is properly stapled andincised. Handle 32 can include pistol grip 54 towards which closuretrigger 46 can be pivotally drawn in order to move anvil 52 towardstaple channel 50 and clamp tissue positioned between anvil 52 andchannel 50. Stated another way, once the clinician is satisfied with thepositioning of end effector 36, the clinician may draw back closuretrigger 46 to a position in which anvil 52 is fully closed and trigger46 is locked into position. Such devices are further described in U.S.patent application Ser. No. 11/343,321, entitled SURGICAL CUTTING ANDFASTENING INSTRUMENT WITH CLOSURE TRIGGER LOCKING MECHANISM, which wasfiled on January 31, the disclosure of which is hereby incorporated byreference herein.

Thereafter, firing trigger 48 may be pivotally drawn toward pistol grip54 to staple and sever the soft tissue clamped in end effector 36. Moreparticularly, referring to FIG. 3, end effector 36 may further includecutting member or knife 60, sled 62, staple cartridge 64 removablypositioned within channel 50, and helical screw shaft 66. Upon anactuation of firing trigger 48, screw shaft 66 can be rotated in orderto motivate cutting member 60 and sled 62 relative to channel 50 suchthat cutting member 60 can incise tissue clamped within end effector 36and sled 62 can deploy staples removably stored in staple cartridge 64.In various embodiments, sled 62 can include a number of sloped surfaceswhich can be configured to drive the staples removably stored in staplecartridge 64 into the clamped tissue. In at least one embodiment, anvil52 can be configured to deform at least a portion of the staples afterthe staples have been inserted into the tissue. Such instruments aredisclosed in U.S. Pat. No. 6,978,921, entitled SURGICAL STAPLINGINSTRUMENT INCORPORATING AN E-BEAM FIRING MECHANISM, which issued onDec. 27, 2005, and U.S. patent application Ser. No. 11/216,562, entitledSTAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMED STAPLEHEIGHTS, which was filed Aug. 31, 2005, the disclosures of which arehereby incorporated by reference herein. In various embodiments, screwshaft 66 can be powered by a hand-powered gear assembly as described inU.S. Pat. No. 5,465,895 mentioned above or by a motor as described inU.S. patent application Ser. No. 11/343,498, entitled MOTOR-DRIVENSURGICAL CUTTING AND FASTENING INSTRUMENT WITH USER FEEDBACK SYSTEM,which was filed Jan. 31, 2006, the disclosure of which is herebyincorporated by reference herein.

In various embodiments, staple cartridge 64 can include staple drivers(not illustrated) positioned therein which can be lifted by sled 62 andcan be configured to drive the surgical staples toward anvil 52. Inother various embodiments, the surgical staples can be lifted directlyby anvil 52. In such embodiments, the crown of the surgical staples caninclude angled, or beveled, surfaces thereon which can cooperate withsled 62 to lift the surgical staples as described above. Such surgicalstaples are described in greater detail in U.S. patent application Ser.No. 11/529,935, entitled SURGICAL STAPLES HAVING ATTACHED DRIVERS ANDSTAPLING INSTRUMENTS FOR DEPLOYING THE SAME, which was filed on Sep. 29,2006, the disclosure of which is hereby incorporated by referenceherein. In various embodiments, referring to FIG. 10, sled 62 can beprogressed through staple cartridge 64 from the position illustrated inFIG. 10 toward distal end 147 of staple cartridge 64. As sled 62 ismoved distally along cartridge 64, sled 62 can engage crowns 122 ofstaples 120 such that staples 120 are successively lifted by sled 62toward anvil 52. More particularly, crowns 122 can include beveledsurfaces 148 (FIGS. 5 and 6) which can be configured to cooperate withangled surface 150 of sled 62 such that crowns 122 can slide up sledsurface 150.

FIG. 4 illustrates the cutting and stapling of tissue 100 with any oneof the various surgical cutting and stapling instruments describedherein. Portion 102 of tissue 100, as illustrated in FIG. 4, has alreadybeen cut and stapled along incision 106. Three rows of staples 107 havebeen inserted by an endocutter 30 into tissue 100 on each side of cutpath 106. After the clinician has cut and stapled first portion 102, theinstrument would be withdrawn to enable new staple cartridge 64 to beinstalled. FIG. 4 illustrates the position of end effector 36 prior tocommencing the second cutting and stapling process. As can be seen inFIG. 4, portion 102 of tissue 100 that has been stapled has a thicknessT′ that is less than the thickness T″ of other portions 104 of tissue100.

In at least one embodiment, referring to FIGS. 5-9, staple 120 mayinclude crown 122 and deformable legs, or members, 124 and 126 extendingtherefrom. In various embodiments, the deformable members may becomprised of an elongate wire having a substantially consistentcross-section. In other various embodiments, legs 124 and 126 caninclude first notches 130, second notches 132, and third notches 133therein. Referring to FIG. 6 owing to the reduced cross-section of legs124 and 126 at first notches 130, for example, legs 124 and 126 can bemore susceptible to deformation at these locations. In at least oneembodiment, when legs 124 and 126 are bent at notches 130, firstsegments 138 may bend at an approximately 90 degree angle, for example,with respect to second segments 140 of legs 124 and 126. In otherembodiments, first segments 138 may be bent at any suitable angle withrespect to second segments 140. In use, referring to FIGS. 5 and 10,when ends 128 of legs 124 and 126 contact pockets 134 of anvil 52, legs124 and 126 may bend inwardly at first notches 130, second notches 132,and third notches 133. In other various embodiments, referring to FIG.10A, staple 120′ can include legs 124′ and 126′ which can be configuredsuch that they are deformed in an outwardly direction, i.e., away fromeach other. In at least one such embodiment, the bases of these staplescan have a length which is shorter than base 121 such that legs 124′ and126′ can contact a portion of anvil pocket 134 and be deformedoutwardly. In various embodiments, as a result, these staples can beused with the same anvil which is used to deform staples 120 inwardly asdescribed above. In addition to the above, although not illustrated, anyother suitable staples described herein can also include legs which canbe configured to be deformed outwardly.

In various embodiments, referring to FIG. 8, as legs 124 and 126 arebeing deformed from the shape illustrated in FIG. 7 to the shapeillustrated in FIG. 8, ends 128 of deformable members 124 and 126 maycontact crown 122. To facilitate the bending of the deformable members,crown 122 may include a forming surface, or anvil, for guiding and/ordeforming legs 124 and 126 when they contact crown 122. In order toguide ends 128, anvil 143 of crown 122 can include recesses 144 whichcan direct ends 128 to move outwardly as illustrated in FIG. 8 or in anyother suitable direction. In various embodiments, recesses 144 may notdeform legs 124 and 126 significantly, however, in the illustratedembodiment, recesses 144 can be configured to deform legs 124 and 126 atan approximately 90 degree angle. In various embodiments, as a result,anvil 52 of stapler 30 and anvil 143 of crown 122 can cooperate todeform staple 120 into the shape illustrated in FIG. 8, for example, orany other suitable shape.

Referring to FIGS. 5 and 6, base 121 of staple 120 can be embedded incrown 122. In various embodiments, crown 122 can be overmolded onto base121, such that crown 122 can tightly surround and envelop base 121. Inat least one embodiment, material 123 can be formed around a singlecontinuous wire comprising base 121 and deformable members 124 and 126.In other embodiments, deformable members 124 and 126 can be separatelyembedded in material 123. In either event, in at least one embodiment,crown 122 can include material 123 overmolded onto base 121 wherematerial 123 can be comprised of a plastic material, such as, forexample, a dissolvable, biofragmentable, or bioabsorbable plasticmaterial. In embodiments using such materials, the plastic material mayinclude Vicryl or PDS from Ethicon, Inc., for example. As used herein,the terms dissolvable, bioabsorbable, and biofragmentable generallyrefer to materials that can be at least partially assimilated by thebody after being implanted into a patient, for example. In variousembodiments, in addition to or in lieu of the above, the plasticmaterial can include a non-dissolvable, non-biofragmentable, ornon-bioabsorbable plastic material. In either event, in various otherembodiments, crown 122 may be separately manufactured and then assembledto base 121.

Further to the above, in at least one embodiment, the dissolvable,biofragmentable, or bioabsorbable materials can at least partiallydissolve during the healing process thereby allowing the tissuecompressed within staple 120 to expand and grow. In at least oneembodiment, referring to FIGS. 11-15, staple 160 can include crown 162,first deformable member 164, and second deformable member 166, wheredeformable members 164 and 166 can each include base 168, deformable leg170, and second leg 172. When staple 160 is initially deployed,deformable members 164 and 166 may apply significant compressive forcesto the soft tissue positioned within staple 160 in order to limitbleeding therefrom. As crown 162 deteriorates, however, the gap betweendeformed members 164 and 166 and crown 162 may increase, therebyrelaxing the compressive forces acting on the soft tissue. In someapplications, relaxing these compression forces during the healingprocess may allow the tissue to slowly expand and return to its normalthickness over a period of time. In some embodiments, crown 162 can becoated with a hydrophilic material that initially expands to compressthe tissue captured within the staple before dissolving away thereafter.In these embodiments, the hydrophilic material can expand by absorbingwater from the surrounding tissue and fluids, for example.

As a result of the above, when a plurality of staples 160 are insertedinto the soft tissue, staples 160 may cause the soft tissue to becomestiff and, in various circumstances, the tissue may not be permitted tomove and expand during the healing process. However, after crowns 162 ofstaples 160 have been at least partially dissolved, deformable members164 and 166 of staples 160 may be able to move relative to each otherwhile still holding the underlying tissue together. More particularly,referring to FIG. 14, the material of crown 162 can deteriorate to thepoint where first member 164 and second deformable member 166 can becomedisconnected from each other as illustrated in FIG. 15. Once firstmember 164 and second member 166 have become disconnected, they can moverelative to one another and the soft tissue can become less stiff. Invarious embodiments, the time required for crown 162 to sufficientlydissolve may depend on the material used and/or the size of crown 162.Polyglatin 910 material, sold under the trade name Vicryl, for example,may dissolve in seven to fourteen days.

In various embodiments, deformable members 164 and 166 can be comprisedof a substantially non-dissolvable or non-bioabsorbable material suchas, for example, titanium, titanium alloy, or stainless steel. In otherembodiments, at least one of deformable members 164 and 166 may becomprised of a bioabsorbable material such as magnesium or iron, forexample. In at least one embodiment, the iron is pure iron. In eitherevent, the dissolvable material of members 164 and 166 can be selectedsuch that they dissolve at the same rate as, slower than, or faster thanthe dissolvable material of crown 162. For example, the material ofcrown 162 can be selected such that it completely dissolves away whiledeformable members 164 and 166 are still holding soft tissue together,for example. Further, in various embodiments, the material of firstdeformable member 164 can be selected such that it dissolves faster thanthe material of second deformable member 166. Accordingly, deformablemembers of 164 and 166 in these embodiments may allow for a staggeredrelease of the tissue. Further to the above, in various embodiments, atleast two adjacent staples 160 can be connected by a bridge beforeand/or after the staples 160 have been deployed into the tissue. Inthese embodiments, a first staple 160 can be comprised of bioabsorbablematerials that dissolve away at a faster rate than the materials of asecond staple 160 attached thereto. Similarly, the bridge connecting thestaples 160 can be comprised of materials that dissolve away at the samerate, and/or a different rate, than the first and second staples 160. Inthese embodiments, the first staples 160 can dissolve away before thesecond staples 160 allowing for a staggered release of the tissuesimilar to the above.

In various embodiments, referring to FIG. 12, crown 162 can includereduced cross-section 174 intermediate portions 176 and 178. In use,intermediate section 174, as it has a smaller cross-section thanportions 176 and 178, may completely dissolve away before sections 176and 178 thereby allowing first member 164 to become unconnected fromsecond member 166 before the entirety of crown 162 has dissolved (FIG.15). In at least one embodiment, the cross-sections of sections 174,176, and 178 can be selected such that deformable members 164 and 166become unconnected at a desired stage in the healing process. In otherembodiments, crown 162 can include score marks (not shown), which mayreduce the thickness of crown 162 in the scored areas. In at least oneembodiment, crown 122 of staple 120 (FIGS. 5-9) and/or crown 162 ofstaple 160 (FIGS. 11-15) may comprise at least one therapeutic drug. Inthese embodiments, as the dissolvable material deteriorates, thetherapeutic drug can be absorbed by tissue surrounding the staple. Insome embodiments, the drug is dispersed throughout the dissolvablematerial such that the drug is steadily released during the healingprocess, however, in other embodiments, the therapeutic drug may beunevenly dispersed throughout the dissolvable material, or layeredwithin and/or on the material, to provide an increased dosage of thedrug at a particular stage in the healing process.

In various embodiments, referring to FIGS. 18-20, surgical staple 200can include base 202, first deformable member 204, and second deformablemember 206 where deformable members 204 and 206 can extend from base202. In at least one embodiment, at least a portion of base 202, firstdeformable member 204 and/or second deformable member 206 can have anon-circular cross-section. More particularly, referring to FIG. 19, thecross-section of deformable member 204, for example, can include arcuateportion 203 and flat portion 205. In various embodiments, referring toFIG. 18, base 202 and deformable members 204 and 206 can comprise wire201, where wire 201 can include a cross-section which is substantiallyconstant throughout the length of wire 201. In other embodiments,however, first deformable member 204 and second deformable member 206,for example, can have different cross-sections. In at least one suchembodiment, first deformable member 204 can include a substantiallycircular cross-section and second deformable member 206 can include anon-circular cross-section. In other various embodiments, firstdeformable member 204 can include a non-circular cross-section which isdifferent than a non-circular cross-section of second deformable member206.

In various embodiments, the cross-sectional geometry of deformablemembers 204 and 206 can control the manner and direction in whichdeformable members 204 and 206 are bent when they are deformed by anvil52 as described above. In at least one embodiment, referring to FIG. 19,flat portions 205 can be oriented such that they are facing each otherand/or axis 207 and, as a result, flat portions 205 can cause deformablemembers 204 and 206 to bend toward axis 207 when a force is appliedthereto. In other various embodiments, flat portions 205 can be orientedin any suitable manner to allow the deformable members to bend in adesired direction. In effect, the size and location of flat portion 205can affect the moment of inertia of the cross-section and,correspondingly, affect the manner in which the deformable membersrespond to the bending stress applied thereto. In such embodiments, thedeformation of deformable members 204 and 206 can be controlled in orderto apply a desired compressive force to the soft tissue captured withinstaple 200. More particularly, in at least one embodiment, thedeformable members can be bent until they contact the soft tissue andapply a compressive force to the soft tissue where the amount of forceis largely determined by the amount and direction in which deformablemembers 204 and 206 are deformed.

In at least one embodiment, referring to FIGS. 19 and 20, crown 208 canbe molded onto or positioned onto base 202, where crown 208 can becomprised of a dissolvable, biofragmentable, or bioabsorbable material.In various embodiments, crown 208 can include a compression surfaceagainst which soft tissue can be pressed when the soft tissue iscaptured within staple 200. In at least one embodiment, referring toFIG. 20, staple 200 can include compression surface 209 wherecompression surface 209 can include a wider profile, or larger surfacearea, than surface 211 of base 202. In such embodiments, as a result,the wider surface area of compression surface 209 may reduce the stressapplied to the soft tissue captured therein. More particularly, for agiven compression force applied to the soft tissue, the resultant stressin the soft issue is inversely proportionate to the area against whichthe compression force is applied. Stated another way, when a force isapplied to the soft tissue over a small area, the resultant stress islarge, and, when the same force is applied to the soft tissue over alarge area, the resultant stress is small. In view of the above, thedimensions of compression surface 209 can be selected in order toachieve a desired stress in the soft tissue captured in staple 200.

In various embodiments, flat portions 205, as described above, cancooperate with compression surface 209 of crown 208 to control and/orreduce the stress applied to the soft tissue captured within staple 200.More particularly, in embodiments where a round portion of thedeformable members contacts the soft tissue, the compressive forceapplied to the soft tissue may be applied across a very small areapotentially resulting in a very high stress concentration in the softtissue. In embodiments where a flat portion of the deformable memberscontacts the soft tissue, the force applied to the soft tissue can beapplied across a greater surface area resulting in a lower stressconcentration. In view of the above, the cross-sectional geometry ofdeformable members 204 and 206 and the dimensions of compression surface209 can be selected such that they cooperate to apply a desired stressto the soft tissue. In embodiments where crown 208 is comprised of adissolvable, biofragmentable, or bioabsorbable material, as describedabove, the compressive force or stress applied to the soft tissue can bereduced as crown 208 is dissolved. More particularly, in at least oneembodiment, flat portions 205 and compression surface 209 can define afirst distance therebetween when staple 200 is initially inserted intothe soft tissue which results in a first force, and stress, beingapplied to the soft tissue and, after at least a portion of compressionsurface 209 has dissolved away, flat portions 205 and compressionsurface 209 can define a larger distance therebetween which can reducethe compressive force and thus, stress, applied to the soft tissue. Invarious embodiments, at least one of deformable members 204 and 206 canbe comprised of a dissolvable, biofragmentable, or bioabsorbablematerial. In such embodiments, portions of deformable members 204 and206 can, similar to the above, dissolve away to reduce the compressiveforce and stress to the soft tissue.

Referring to FIGS. 21-26, staple 252 can include first deformable member256 and second deformable member 258 where each deformable member caninclude base 260, first deformable leg 262, and second deformable leg263. Staple 252 can also include crown 254 which can be comprised of atleast one overmolded or co-molded material. In at least one embodiment,crown 254 may be comprised of a first material overmolded ontodeformable members 256 and 258 and a second material overmolded onto thefirst material, for example. In at least one such embodiment, the secondmaterial can be configured to dissolve away quickly thereby allowingdeformable members 256 and 258 to separate from each other early in thehealing process. The first material, however, can be selected todissolve at a slower rate than second material in order for crown 254 ofstaple 252 to continue to provide a compressive force on the tissue evenafter the second material has completely dissolved away. In at least oneembodiment, the first material can be injection molded onto deformablemembers 256 and 258 and then permitted to cure, and/or substantiallysolidify, before the second material is injection molded onto the firstmaterial. In other various embodiments, the first material and thesecond material can be injection molded onto deformable members 256 and258 at substantially the same time or in rapid succession. In theseembodiments, the first and second materials can chemically bond togetherto provide sufficient strength therebetween so that staple 252 may behandled without the first and second materials separating from oneanother. In other embodiments, the first and second materials can formmechanically interlocking features to accomplish the same result.

Similar to the above, referring to FIGS. 21-26, at least portions ofdeformable members 256 and 258 can include a non-circular cross-section.In the various embodiments illustrated in FIGS. 34-57, thecross-sections of the deformable members can include variouscombinations of flat, arcuate, and/or radiused surfaces. In theembodiment illustrated in FIGS. 34 and 35, for example, thecross-section of a deformable member can include a plurality of arcuatesurfaces 282. In the embodiment illustrated in FIGS. 36 and 37, thecross-section of a deformable member can include a plurality ofsubstantially flat surfaces 278 and 280. In various embodiments, thecross-section can comprise a triangle, a rectangle, a square, an oval, ahexagon, a pentagon, a trapezoid or any other suitable shape. In eitherevent, the cross-sections can be symmetrical or asymmetrical. In variousembodiments, the cross-sections can be configured, as described above,to allow the deformable members to bend in a particular direction. In atleast one embodiment, referring to FIGS. 40 and 41, flat surfaces 278and 280 can include grooves, or recesses, 283 which can reduce themoment of inertia of the cross-section about at least one axis where thedeformable member is more susceptible to bending about such an axis.

As described above, when deformable members 256 and 258, for example,are inserted through soft tissue, the deformable members can puncturethe soft tissue creating holes therein. As a result, eventhough thedeformable members can substantially fill the puncture holes, blood mayflow, at least initially, from the soft tissue surrounding the punctureholes. In various embodiments of the present invention, at least aportion of the deformable members can expand and apply a compressiveforce against the soft tissue in order to stop, or at least reduce,bleeding from the soft tissue surrounding the puncture holes. In atleast one embodiment, referring to FIGS. 27-33, at least a portion offirst and second deformable members 256 and 258 can be coated withexpandable coating 274. In various embodiments, referring to FIG. 28,expandable coating 274 can have a first diameter when it is initiallyinserted into the soft tissue and can apply, depending upon the size ofthe deformable members and the puncture holes, a first compressive forceto the soft tissue surrounding the deformable members. Thereafter,referring to FIG. 32, expandable coating 274 can increase in size toapply a larger, or second, compressive force to the soft tissuesurrounding the deformable members. In various embodiments, this secondcompressive force may be sufficient to close, or at least constrict, theblood vessels in the soft tissue surrounding the puncture hole toeliminate, or at least reduce, the flow of blood therethrough.

In various embodiments, expandable coating 274 can be comprised of ahydrophilic material, or any other suitable material which has anaffinity for water, that can absorb blood, or other fluids in thesurgical site, in order to expand as described above. In at least oneembodiment, a fluid can be introduced into the surgical site which cancause expandable coating 274 to expand. In various embodiments,expandable coating 274 can be comprised of a cross-linked ester compoundhaving a polyethylene glycol base polymer, for example. In at least onesuch embodiment, expandable coating 274 can be overmolded onto at leasta portion of staple 252 using an injection molding process. In othervarious embodiments, the deformable members and/or crown can be entirelycomprised of an expandable material. In either event, after expandablematerial 274 has expanded, at least a portion thereof can begin todissolve and can be absorbed by the patient's body. In such embodiments,the second compressive force applied to the soft tissue can be relaxedand the soft tissue can be permitted to expand and grow in order to fillthe puncture holes. Such embodiments can be particularly useful when thedeformable members are also comprised of dissolvable or bioabsorbablematerials as described above. In various embodiments, the expandablecoating can also comprise a therapeutic agent, for example, which can bereleased as expandable coating 274 is dissolved.

While expandable coating 274 is demonstrated in connection with a staplehaving deformable members with substantially circular cross-sections,expandable coating 274 can also be applied to deformable members havinga non-circular cross-section including, but not limited to, thecross-sections disclosed in FIGS. 34-57. In other various embodiments,expandable coating 274 can be applied to any other suitable type ofsurgical fastener. In at least one such embodiment, a suture, orsurgical thread, can be at least partially coated with an expandablecoating. In use, the suture, or thread, can create puncture holes in thesoft tissue when they are inserted therein and the expandable coatingcan expand to fill the puncture holes as described above.

In various embodiments, referring to FIGS. 58-66, staple 302 can includebase 304, first deformable member 306, and second deformable member 308.In at least one embodiment, staple 302 can further include crown 310having apertures 312 defined therein which can be configured to receivefirst deformable member 306 and second deformable member 308. Asdescribed in further detail below, deformable members 306 and 308 can beconfigured to move, or slide, within apertures 312 such that base 304can be moved relative to crown 310. In at least one such embodiment,each aperture 312 can define an axis 314 extending therethrough wheredeformable members 306 and 308 can be configured to move along axes 314when they are moved within apertures 312. In various embodiments, crown310, referring to FIGS. 61-63, can include recess 320 which can beconfigured to receive base 304 and at least limit, if not prevent,relative movement between base 304 and crown 310. In at least oneembodiment, base 304 can be movably positioned within recess 320 suchthat recess 320 can permit deformable members 304 and 306 to move alongaxes 314 but at least inhibit base 304 from moving transversely to axes314. In various embodiments, recess 320 can be configured to receivebase 304 in a press-fit and/or snap-fit configuration such that, oncebase 304 is positioned in recess 320, base 304 can be substantiallyimmovable relative to crown 310.

In various embodiments, referring to FIGS. 67-70, staples 302 can beremovably stored within a staple cartridge, such as staple cartridge318, for example. In at least one embodiment, staple cartridge 318 caninclude body 326 having cavities 316 defined therein. Staple cartridgebody 326 can further include deck 328 having top surface 330 wherecavities 316 can include an opening in top surface 330. In variousembodiments, each cavity 316 can be configured to receive at least aportion of a base 304 and deformable members 306 and 308 of a staple 302where deck 328 can include recesses 334 which can be configured toreceive crowns 310. In use, referring to FIG. 67, base 304 can besituated in a first position in cavity 316 before it is moved towardcrown 310. In at least one embodiment, deformable members 306 and 308can include ends 336 where, in this first position, ends 336 can bepositioned within or proximal to apertures 312. In such embodiments, asa result, when deformable members 306 and 308 are moved relative tocrown 310 as described above, deformable members 306 and 308 can alreadybe aligned with axes 314 and the possibility of deformable members 306and 308 becoming misaligned with apertures 312 can be reduced.

In various embodiments, referring to FIGS. 67 and 68, deformable members306 and 308 and base 304 can be moved, or slid, relative to crown 310 bydriver 338. In at least one embodiment, the staple cartridge can furtherinclude a sled configured to lift driver 338 and move base 304 towardcrown 310. Although the sled is not illustrated in FIGS. 67 and 68,exemplary sleds are described and illustrated in the present applicationincluding sled 62 in FIGS. 3 and 10. In various embodiments, referringto FIG. 68, driver 338 can push or slide base 304 until base 304contacts crown 310 and engages recess 320 as described above anddeformable members 306 and 308 are inserted into soft tissue positionedabove top surface 330. Thereafter, referring to FIG. 69, base 304 andcrown 310 can be forced upwardly by driver 338 such that crown 310 isremoved from recess 334. In various embodiments, crown 310 can bepress-fit or snap-fit within recesses 334 such that driver 338 mustapply a sufficient force to dislodge crown 310 from recess 334. In othervarious embodiments, although not illustrated, crown 310 can beintegrally molded with deck 328 such that driver 338 must apply asufficient force to base 304 to break crown 310 away from staplecartridge body 326.

In various embodiments, driver 338 can be configured to drive deformablemembers 306 and 308 against an anvil such that the deformable membersare deformed by the anvil, as described above. Thereafter, as describedabove, the deformable members can capture the soft tissue and compressit against crown 310. In various embodiments, crown 310 may furtherinclude tissue-contacting surface 324 which can be used to control thecompressive pressure applied to the soft tissue. More particularly, whensurface 324 includes a large area against which the soft tissue can becompressed, the compressive pressure applied to the soft tissue can bemuch less than when surface 324 includes a smaller area. In at least oneembodiment, tissue-contacting surface 324 can have a first width andbase 304 can have a second width. In at least one such embodiment, thefirst width of tissue-contacting surface 324 can be wider than thesecond width of base 304 such that only tissue-contacting surface 324comes into contact with tissue during staple 302 deployment or firing.

In various embodiments, tissue can be captured and compressed betweenstaple cartridge 318 and the anvil before staples 302 are deployed intothe soft tissue. In at least one embodiment, crowns 310 can bepositioned within recesses 334 of staple cartridge body 326 such thatsurfaces 324 of crowns 310 can be aligned, or substantially flush, withtop surface 330 of deck 328. In at least one such embodiment, thecompressive force, or pressure, applied to the soft tissue by deck 328and crowns 310 can be substantially the same. In other variousembodiments, crowns 310 can be positioned within recesses 334 such thatsurfaces 324 are positioned above top surface 330 of staple deck 328. Insuch embodiments, the compressive force, or pressure, applied to thesoft tissue by crowns 310 can be greater than the compressive force, orpressure, applied by deck 318. In various embodiments, the relativedistance between surfaces 324 and top surface 330 can be selected toprovide a desired pre-deployment compression force, or pressure, to thesoft tissue. In other various embodiments, surfaces 324 can bepositioned below top surface 330 of deck 328 such that the compressionforce, or pressure, applied to the soft tissue by surfaces 324 is lessthan the compressive force, or pressure, applied by deck 328.

In various embodiments, referring to FIGS. 59, 62, and 65, staple 302′can include deformable members 306 and 308 which may be configured topierce crown 310′ in lieu of passing through apertures 312. In suchembodiments, ends 336 of the deformable members can be sharp enough topuncture crown 310′ and create holes therein which can allow deformablemembers 306 and 308 to move, or slide, relative thereto. In othervarious embodiments, referring to FIGS. 60, 63, and 66, deformablemembers 306″ and 308″ can be positioned outside the perimeter of crown310″. In at least one such embodiment, although not illustrated, crown310″ can include recesses, or slots, which can be configured to slidablyreceive deformable members 306″ and 308″.

In various embodiments, referring to FIGS. 72-76, several staples can beconnected together in order to control the distribution of thecompressive force or pressure applied to the soft tissue captured withinthe staples. In at least one embodiment, the crowns 310 of severalstaples 302 can be connected together by bridges 340 such that bridges340 and crowns 310 can apply a compressive force to the soft tissue overa larger area and reduce the pressure and stress applied to the softtissue. In various embodiments, bridges 340 can also assist inpreventing a staple 302 from tearing through or being pulled from thesoft tissue. More particularly, when an excessively high force isapplied to a particular staple 302, this force can be distributed to oneor more other staples 302 in the soft tissue via bridges 340 andpossibly prevent the soft tissue from being damaged. In variousembodiments, tissue-contacting surfaces 324 can be positioned abovebridges 340 such that bridges 340 apply a lesser compressive force, orpressure, to the soft tissue than crowns 310. In other variousembodiments, although not illustrated, the top surfaces of bridges 340can be aligned, or substantially flush, with surfaces 324 such thatcrowns 310 and bridges 340 can apply substantially the same compressiveforce, or pressure, to the soft tissue. In various embodiments, bridges340 can be flat, contoured, arcuate or any other suitable shape and canhave any suitable cross-sectional arrangement.

In various embodiments, referring to FIGS. 74 and 75, staple cartridge318 can further include intermediate recesses 342 defined in deck 328where recesses 342 can be configured to accept bridges 340. In variousembodiments, bridges 340 can be positioned within recesses 342 such thatthey can be removed therefrom when staples 302 are deployed as describedabove. In other various embodiments, bridges 340 can be press-fit,snap-fit, or integrally molded with deck 328. Similar to the above, astaple driver can be configured to apply a sufficient force to staples302 and/or bridges 340 to dislodge bridges 340 from deck 328. In eitherevent, the driver, although not illustrated in FIGS. 72-76, can beconfigured to deploy the connected staples 302 at substantially the sametime. In other various embodiments, bridges 340 can be flexible enoughto permit the driver to deploy the connected staples 302 in series. Invarious embodiments, although not illustrated, more than one bridge 340can be used to connect the crowns 310 of adjacent staples 302. In atleast one embodiment, four or more adjacent staples 302 can be connectedto each other by bridges 340, however other embodiments are envisionedincluding more than or less than four connected staples.

In various embodiments, referring to FIG. 74, staples 302 can bepositioned in several rows, or lines, where bridges 340 can connectstaples 302 which are in the same row and/or in different rows. By wayof example, referring to FIGS. 74-76, crowns 310 of staples 302 in afirst row can be connected while, in the same embodiment, the crowns 310of these staples can be connected to crowns 310 of staples 302 in asecond and/or third row. In various embodiments, bridges 340 and crowns310 can be injection molded onto bases 304. In at least one embodiment,bridges 340 and crowns 310, or portions thereof, can be comprised of anabsorbable, biofragmentable, or dissolvable material. In variousembodiments, bridges 340 and crowns 310 can be at least partiallycomprised of a therapeutic drug as discussed above.

In various embodiments, as described above, soft tissue can becompressed between an anvil and a staple cartridge, for example, beforestaples are deployed from the staple cartridge. In various embodiments,referring to FIG. 84, soft tissue 360 can be compressed between anvil346, top surface 330 of staple cartridge 318, and tissue contactingsurfaces 324 of staple crowns 310. In at least one embodiment, suchcompression can push blood, or other fluids, out of soft tissue 360 andreduce the thickness of soft tissue 360 before the staples are insertedtherein which can allow the staples to achieve a greater clamping force,or purchase, in the soft tissue. In at least one embodiment, anvil 346can include compression surface 350 which can be configured to contactsoft tissue 360 as described above. In various embodiments, compressionsurface 350 can include anvil pockets 348 defined therein which can beconfigured to receive and deform ends 336 of deformable members 306 and308 such that staples 302 can capture soft tissue 360 therein. In atleast one embodiment, however, soft tissue 360 can flow into anvilpockets 348 thereby allowing the soft tissue to expand before thestaples are inserted therein. As a result, the soft tissue may bethicker in the areas underlying pockets 348, and, correspondingly, thesoft tissue surrounding deformable members 306 and 308, which can reducethe clamping force or purchase of the staples in the soft tissue.

In various embodiments, the surgical staples, for example, can includefeatures which can inhibit, or even prevent, this phenomenon fromoccurring. More particularly, referring to FIGS. 77-79, staples 302 caninclude projections 344 extending from crown 310 which can cooperatewith anvil pockets 348 to determine the pressure of the soft tissuepositioned therebetween. In at least one embodiment, projections 344 canbe configured such that the distance between projections 344 and anvilpockets 348 is substantially the same distance as the distance betweentissue contacting surfaces 324 of crowns 310 and tissue compressionsurface 350 of anvil 346. In these embodiments, as a result, the force,or pressure, applied to the soft tissue can be substantially uniformbefore staples 302 are deployed therein. In other various embodiments,the distance between projections 344 and anvil pockets 348 can besmaller than the distance between staple surfaces 324 and anvilcompression surface 350. In such embodiments, the force, or pressure,applied to the soft tissue can be greater in the areas of the softtissue surrounding deformable members 306 and 308. In at least oneembodiment, as a result, a greater amount of blood, or fluids, can beremoved from the soft tissue surrounding deformable members 306 and 308and a greater clamping force or pressure can be generated by staples302. In various embodiments, projections 344 can also cooperate withanvil pockets 348 to reduce bleeding from the soft tissue at punctureholes created in the soft tissue by deformable members 306 and 308. Insuch embodiments, projections 344 can essentially act as a clamp and canameliorate problems associated with bleeding from the soft tissuesurrounding the puncture holes.

In various embodiments, as described above, projections 344 can belocated adjacent to deformable members 306 and 308, however, otherembodiments are envisioned in which one or more projections can beutilized in any suitable location on the staple to control the force, orpressure, applied to the soft tissue. In at least one embodiment,projections 344 can be integrally formed with crown 310 a during aninjection molding process, for example, and/or projections 344 can beassembled to staples 302. In either event, projections 344 can becomprised of the same material as, or a different material than, thematerial comprising crown 310. While projections 344 have been describedand illustrated as being generally semicircular portions, projections344 can include any other suitable shape that can compress tissue withinanvil pockets 348, for example. In various embodiments, although notillustrated, projections 344, or any other suitable projections, canextend from deck 328 of staple cartridge 318 and/or deformable members306 and 308.

In various embodiments of the present invention, surgical staples can beproduced by an injection molding process. In at least one embodiment,referring to FIGS. 85-88 and 105, elongate member 402 may be placed intoa mold. In various embodiments, elongate member 402 can be placeddirectly into the mold or, alternatively, referring to FIG. 105,elongate member 402 can be placed into transfer block 404 and thentransfer block 404 can then be placed into the mold as described ingreater detail below. In either event, referring to FIG. 85, elongatemember 402 can comprise a plurality of deformable members 406 where eachdeformable member 406 can include a base 408 and at least one leg 410.

In various embodiments, elongate member 402 may be comprised of anysuitable material such as plastic, titanium, or any other suitablemetal. In at least one embodiment, referring to FIG. 85, elongate member402 can be comprised of a wire and can have a generally serpentineshape. In various embodiments, the term “serpentine shape” can includeany non-linear shape which can allow the elongate member to be separatedinto two staple portions. In at least one embodiment, elongate member402 can be formed into a generally serpentine shape before and/or duringthe placement of elongate 402 into the mold or transfer block 404.

Further to the above, elongate member 402 can have a crosssectional-shape comprising any of the shapes discussed above or anyother cross sectional-shape suitable for making staples.

In various embodiments, referring to FIG. 105, elongate member 402 canbe placed in the mold or transfer block 404 such that the bases 408 ofdeformable members 406 can be situated in a plurality of pre-definedcavities 409. In at least one embodiment, the mold can be closed suchthat molten material can then be injected into sprue cavities 411 andflow into runner cavities 403 in order to fill cavities 409 with themolten material and at least partially encapsulate bases 408, forexample. In various embodiments, the molten material can include aplastic, a metal, and/or any other suitable material. Once cavities 409have been filled with the molten material, the flow of molten materialmay cease and, referring to FIG. 86, the molten material can then hardento form overmolded crowns 426. In various embodiments, crowns 426 mayhave the shape of cavities 409 and, in at least one embodiment, crowns426 can also be formed onto at least a portion of legs 410. Thereafter,in various embodiments, elongate member 402 can comprise staple strips412 which may be joined together by connection segments 434 and legs 410of first staples 413 and second staples 415.

In various embodiments, as mentioned above, each staple strip 412 caninclude connection segments 434 as a result of the molding process. Moreparticularly, the mold or transfer block 404 can include runner cavities403 which can place cavities 409, for example, in fluid communicationwith each other. Such runner cavities 403 can be useful for assuringthat each cavity 409 is filled with molten material and, owing to themolten material that hardens in runner cavities 403, connection segments434 can extend between crowns 426 of first and second staples 413 and415, for example. Referring to FIG. 87, in various embodiments,connection segments 434 may be removed from first staples 413 and secondstaples 415. In at least one embodiment, the connection segments 434 canbe removed from the staples by a cutting mechanism or hot knife, forexample, operably engaged with the mold and/or transfer block 404. Inother embodiments, connection segments 434 can be removed from staples413 and 415 after staple strips 412 have been removed from the moldand/or transfer block 404. In other various embodiments, connectionsegments 434 can remain connected to staples 413 and 415 when staplestrips 412 are loaded into a staple cartridge and, in variousembodiments, connection segments 434 can be removed from, or remainconnected to, staple strips 412 after they are deployed from the staplecartridge.

After, before, or contemporaneous with the removal of connectionsegments 434, staple strips 412 can be cut in order to separate firststaples 413 from second staples 415. In various embodiments, referringto FIG. 88, staple legs 410 can be cut along line 401 such that staplelegs 410 are substantially the same length. In alternative embodiments,referring to FIG. 87, staple legs 410 can be cut along lines 401′ and/or401″, for example, such that staple legs 410 are different lengths. Invarious embodiments, staples having shorter legs can provide a differentcompression force, or pressure, to soft tissue captured therein, forexample, than staples having longer legs. In such embodiments, legs 410can be cut to a desired length such that they can apply a desiredcompression force, or pressure, to the soft tissue. In either event, invarious embodiments where connection segments 434 have not yet beenremoved, referring to FIG. 88, legs 410 of first staples 413 can beseparated from legs 410 of second staples 415 in order to separatestaple strips 412. Although staple strips 412 are illustrated assubstantially linear staple strips, staple strips 412 can form acircular ring of staples or any other suitable configuration. Inembodiments where connection segments 434 have already been removed,referring to FIG. 87, the cutting process can separate first staples 413from second staples 415.

In various embodiments, referring to FIG. 105, the cutting process mayoccur through the use of transfer block 404 when elongate member 402 hasbeen positioned therein. More particularly, transfer block 404 caninclude a plurality of slots 428 which can be configured to receive acutting member (not illustrated) where the cutting member can sever legs410 as described above. In at least one embodiment, the cutting membercan be configured to sever legs 410 at any suitable location withinslots 428 such that staple legs 410 can be cut to a suitable length. Invarious embodiments, first staple 413 can be cut such that it hasshorter legs 410 than second staple 415, for example. In other variousembodiments, the cutting member can also sever legs 410 at more than onelocation within slot 428. In such embodiments, the transfer block 404can remain closed and hold staple strips 412 in place while legs 410 arebeing separated. In other embodiments, the cutting step may occur afterthe mold or transfer block 404 is opened. In various embodiments, thecutting step can be performed after transfer block 404 has been removedfrom the mold such that the cutting step can be performed at a cuttingstation, by hand or by any other suitable cutting method.

In various embodiments, the method of making staples can include anautomated process. In at least one embodiment, the automated process caninclude a wire forming machine which can bend wire to form elongatemembers 402. The automated process can further include transfer block404 which can be positioned on a rotary table or conveyor and can beconfigured to receive elongate members 402. In various embodiments, theautomated process can further include a robotic arm or other transfermechanism for positioning one or more elongate members 402 withintransfer block 404. Thereafter, the automated process can utilize ashuttle mechanism, for example, for moving transfer block 404 into themold where the molten material can be injected therein. In variousembodiments, the shuttle mechanism, for example, can remove transferblock 404 from the mold such that transfer block 404 can be moved to acutting station as described above to cut elongate member 402 and/orconnection segments 434. In other embodiments, as outlined above, thiscutting step can occur while transfer block 404 is positioned within themold. In either event, transfer block 404 can be opened and staplestrips 412 and/or the singulated staples 413 and 415 can be removed andthe automated process can be repeated.

In other various embodiments, referring to FIG. 89, the deformablemembers 406′ of elongate member 402′ can each include two bases 408′,two legs 410′, and intermediate portion 420 which can connect bases408′. In at least one embodiment, referring to FIG. 90, intermediateportion 420 can be severed to create two middle legs 418. In othervarious embodiments, referring to FIGS. 91-93, deformable members 406″of elongate member 430 can be arranged such that the staples arepositioned in a side-by-side configuration and joined by connector 432.In such embodiments, each staple can have two deformable legs 424, twobases 416 and, in at least one embodiment, intermediate portion 420 canbe separated to create two middle legs 418 as described above. In atleast one such embodiment, referring to FIG. 106, elongate member 430can be positioned within a transfer block 404′, for example, such thatcrown 426′, referring to FIG. 92, can be molded onto bases 416. In atleast one various embodiment, transfer block 404′ can include aperturesor slots 428′ through which a cutting member can be operably engaged toseparate connector 432 from legs 424. In various embodiments, similar tothe above, the cutting member can be configured to sever legs 424 atdifferent locations within slot 428′ in order to selectively cut staplelegs 424 to a desired length.

In other various embodiments, referring to FIGS. 94-104, separatedeformable members 436 can be positioned within the mold and/or transferblock 404″. In at least one such embodiment, referring to FIG. 94,individual deformable members 436 can include at least one leg 438 andbase 440 wherein each base 440 can be positioned within a cavity 409″ ofthe mold or transfer block 404″, referring to FIG. 104, to receive crown426″ molded thereon.

In various embodiments of the present invention, as outlined above,surgical staples can be removably stored within a staple cartridge andcan be deployed from the staple cartridge by a sled which can beconfigured to traverse the staple cartridge. In at least one embodiment,as described above, the staple cartridge can further include driverswhich can be lifted by the sled and can, correspondingly, deploy thestaples from the staple cartridge. In various embodiments, as alsodescribed above, the staples can include features which can cooperatedirectly with the sled such that the staples can be deployed from thestaple cartridge without drivers. In either event, the staples can bemoved within staple cavities in the staple cartridge as they aredeployed and, in various circumstances, the staples may rotate, or tilt,within the staple cavities which can cause the staples to be deployed inan undesired orientation or become stuck within the staple cavities. Invarious embodiments of the present invention, the staples and/or thestaple cartridge cavities can include features which can at leastinhibit, if not prevent, unwanted rotation, or tilting, of the staples.

In various embodiments, referring to FIGS. 107-110, staple cartridge 451can include at least one staple cavity 452 defined therein. In at leastone embodiment, referring primarily to FIGS. 109 and 110, staple cavity452 can include one or more arcuate portions, or sides, 454 which can beconfigured to cooperate with a surgical staple positioned within thecavity 452 such that the staple does not substantially rotate relativeto axis 450. In various embodiments, referring to FIGS. 111 and 112,surgical staple 456 can include crown 462 and at least one leg 460,where crown 462 can include arcuate portions, or sides, 464 which can beconfigured to cooperate with arcuate portions 454 of staple cavity 452.More particularly, arcuate portions 454 of staple cavity 452 can providebearing surfaces against which arcuate portions 464 of staple 456 canabut as staple 456 is moved along the z-axis of the cavity, or axis 450,and prevent, or at least inhibit, staple 456 and crown 462 from tilting,or rocking, within cavity 454. In at least one embodiment, arcuateportions 464 of crown 462 can frictionally engage arcuate portions 454of cavity 452 such that there is a substantially uniform friction forceacting on arcuate portions 464 of crown 462. In various circumstances,referring to regions 465 in FIG. 110, for example, arcuate portions 454can also allow cavities 452 to be positioned in a tightly packedarrangement.

In various embodiments, referring to FIGS. 111-113, arcuate portions 464of staple 456 can comprise cylindrical, or at least partiallycylindrical, portions where the cylindrical portions can prevent staple456 from tilting, or rocking, within staple cavity 452. Moreparticularly, the cylindrical portions can cooperate with arcuateportions 454 of staple cavity 452 such that one end of staple 456 doesnot substantially dip or raise above the other end of staple 456. In atleast one embodiment, referring to FIGS. 110-112, staple 456 can includedistal end 457 and proximal end 459 and, in addition, staple cavity 452can include distal end 461 and proximal end 463. In various embodiments,ends 461 and 463 of cavity 452 can be configured to guide crown 462along axis 450 such that ends 457 and 459 do not substantially tilt, orrock, toward or away from axis 450. In such embodiments, as a result,deformable members 460 can be deformed by an anvil at substantially thesame time and can be deformed substantially the same amount to applysubstantially the same compressive force to the soft tissue captured instaple 456. In various embodiments, the crown of the surgical staple caninclude an entirely arcuate side (not illustrated) and the staplecavity, referring to FIG. 116, can include an arcuate side wall 454which can be configured to cooperate with the arcuate side of the stapleas described above.

Although arcuate and cylindrical portions are described above, thepresent invention is not limited to such configurations. In variousembodiments, referring to FIGS. 110-112, staple cavities 454 can includesubstantially rectangular notches 470 which can be configured to receiveprojections 486 extending from crown 462. In at least one embodiment,notches 470 and projections 486 can be configured to prevent, or atleast inhibit, staples 456 from rotating or tilting within cavities 454as described above. In various embodiments, referring to FIGS. 114-116,the crown of the surgical staple can include at least one diagonal, orangled, portion (not illustrated) where the staple cavity can include acooperating diagonal, or angled, portion 472. In various alternativeembodiments, referring to FIG. 110A, staple cartridge 451′ can includestaple cavities 452′ where cavities 452′ can include one or more square,or at least substantially square, corners 454′. In such embodiments,corners 454′ can be configured to cooperate with corresponding square,or substantially square, corners on staples positioned within cavities452′ in order to prevent, or at least limit, relative movement about thex and y axes illustrated in FIG. 110A. In various embodiments, when astaple sled is moved within staple cartridge 451′ in a directionillustrated by arrow D, the sled can shift the staples within cavities452′ in direction D causing one or more square corners of the staple tosit flushly within square corners 454′. In these circumstances, thecooperating square features can prevent, or at least resist, the staplesfrom rotating about the x and y axes, for example. Further to the above,the alignment of the square corners can also prevent, or at leastinhibit, the staples from becoming wedged, or caught, within staplecavities 452′. In various embodiments, as illustrated in FIG. 110A,staple cavities 452′ can include both arcuate and square features andreceive at least the benefits of each feature described above.

In various embodiments, referring to FIGS. 107-110, staple cartridge 451can include staple cartridge body 453 including first end 474 and secondend 476. In at least one embodiment, slot 478 can be formed betweenfirst end 474 and second end 476 where slot 478 can be configured toaccept a cutting member. Further to the above, slot 478 can define firstside 480 and second side 482 of staple cartridge body 453 where aplurality of staple cavities 452 can be defined in staple cartridge body453 on first side 480 and/or on second side 482. In at least oneembodiment, cavities 452 on both first side 480 and second side 482 canbe transversely situated, or oriented in an acute angle, with respect toslot 478 and, in at least one embodiment, cavities 452 can besubstantially parallel to each other.

In various embodiments, as described above, surgical staplers can beconfigured to deploy surgical staples in parallel rows on opposite sidesof an incision. In such embodiments, referring to FIG. 117, one or morerows of staples 500 can be used to join together or compress soft tissue502 in order to prevent or reduce bleeding from the soft tissue on bothsides of incision 504, for example. In various embodiments, these rowsof staples 500 can be off-set, or staggered, relative to each other suchthat staples 500 can overlap each other and constrict blood vessels insoft tissue 502, especially blood vessels that extend perpendicular, orsubstantially perpendicular, to incision 504. Although such a staplepattern can be suitable for its intended purpose, improvements can bemade thereto, especially in relation to blood vessels which extend in atransverse and/or parallel direction to incision 504.

In various embodiments, referring to FIGS. 118 and 119, staple cartridge506 can include staple cartridge body 508 where staple cartridge body508 can include top surface 510, bottom surface 512, distal end 514,proximal end 516, and two side walls 518. In at least one embodiment,side walls 518 of staple cartridge body 508 can extend between topsurface 510 and bottom surface 512, and top and bottom surfaces 510 and512 can be defined between distal end 514 and proximal end 516. Invarious embodiments, referring to FIGS. 118 and 119, staple cartridgebody 508 can further include slot 520 where the longitudinal axis ofslot 520 can be parallel to, or substantially parallel to, alongitudinal axis of body 508. In at least one embodiment,“substantially parallel”, for purposes herein, can mean being withinabout 15 degrees of parallel in either direction. In variousembodiments, slot 520 can be defined through proximal end 516 and/ordistal end 514 and can be configured to receive a cutting member adaptedto sever soft tissue, for example. In either event, slot 520 can definefirst side 522 and second side 524 of staple cartridge body 508.

In various embodiments, referring to FIGS. 118 and 119, staple cartridgebody 508 can include at least one first staple cavity 526 and at leastone second staple cavity 528 where first cavity 526 and second cavity528 can be defined in top surface 510 and/or bottom surface 512. In atleast one embodiment, first cavity 526 and second cavity 528 can besituated on first side 522 and/or on second side 524 of staple cartridgebody 508. In various embodiments, first cavity 526 and second cavity 528can each have a first end 530 and a second end 532 where first axis 534can be defined between first end 530 and second end 532 of first cavity526 and, similarly, second axis 536 can be defined between first end 530and second end 532 of second cavity 528. In at least one suchembodiment, first axis 534 of first cavity 526 can be transverse tosecond axis 536 of second cavity 528 such that axes 534 and 536 cancreate an acute or obtuse angle therebetween. In other variousembodiments, first axis 534 of first cavity 526 may be perpendicular to,or substantially perpendicular to, second axis 536 of second cavity 528.In various embodiments, still referring to FIGS. 118 and 119, aplurality of first cavities 526 can be parallel to, or substantiallyparallel to, one another and, likewise, a plurality of second cavities528 can be parallel to, or substantially parallel to, one another. Inother various embodiments, neither the plurality of first cavities 526nor the plurality of second cavities 528 may be parallel to, orsubstantially parallel to, each other.

In at least one embodiment, first cavity 526 can be configured toreceive a first staple and second cavity 528 can be configured toreceive a second staple where each staple can include a first leg 544and a second leg 546. In at least one embodiment, referring to FIG. 120,first leg 544 of the first staple may be situated at first end 548 offirst cavity 538 and second leg 546 of first staple may be situated atsecond end 550 of first cavity 538. In a similar fashion, first leg 544of second staple may be situated at first end 548 of second cavity 540and second leg 546 of second staple may be situated at second end 550 ofsecond cavity 540. In various embodiments, both first leg 544 of thefirst staple and second leg 546 of the second staple can lie on, or bepositioned closely proximate to, common axis 552. In such embodiments,common axis 552 can define first common axis side 554 and second commonaxis side 556. In various embodiments, second leg 546 of the firststaple in first cavity 538 may lie on first common axis side 554 andfirst leg 544 of the second staple in second cavity 540 may lie onsecond common axis side 556. As a result of such a configuration,referring to FIG. 120, for example, the first and second staples can beconfigured to compress, or constrict, blood vessels which extendperpendicular to axis 552 and, in addition, blood vessels which extendtransverse and/or parallel to axis 552.

In various embodiments, referring to FIG. 120, first axis 558 may bedefined between first leg 544 and second leg 546 of the first staplewithin first cavity 538, and, similarly, second axis 560 may be definedbetween first leg 544 and second leg 546 of the second staple withinsecond cavity 540. In at least one embodiment, first axis 558 can betransversely situated with respect to second axis 560 such that, ineffect, first cavity 538 and second cavity 540 can be situatedtransversely with respect to each other. In other various embodiments,first axis 558 can be perpendicular to, or substantially perpendicularto, second axis 560 such that first cavity 538 and second cavity 540 areperpendicularly situated with respect to each other.

In various embodiments, referring to FIG. 121, staple cartridge body 508can include a plurality of first cavities 562 and a plurality of secondcavities 564 defined therein which can be configured to receive firstand second staples, respectively, where the staples can each include afirst leg 568 and a second leg 570. In various embodiments, similar tothe above, first legs 568 of the first staples can be situated at firstends 574 of first cavities 562 and, similarly, second legs 570 of thefirst staples can be situated at second ends 576 of first cavities 562.In at least one embodiment, first legs 568 of the second staples can besituated at first ends 574 of second cavities 564 and second legs 570 ofthe second staples may be situated at second ends 576 of second cavities564. In various embodiments, again referring to FIG. 121, first legs 568of the first staples can be positioned on one side of axis 578 andsecond legs 570 of the first staples can be positioned on the other sideof axis 578. In at least one embodiment, first legs 568 of the secondstaples can be positioned on the same side of axis 578 as second legs570 of the first staples. In various embodiments, second legs 570 of thesecond staples can be positioned on the opposite side of axis 578 thatfirst legs 568 of the second staples are positioned on. In other variousembodiments, the first and second staples can be arranged in any othersuitable configuration as long as legs 568 and 570 of first staples 566and legs 568 and 570 of second staples 572 are each respectivelysituated on opposite sides of common axis 578.

In various embodiments of the present invention, buttress material canbe used to stiffen and/or strengthen soft tissue after it has beenstapled. In at least one embodiment, referring to FIGS. 122-127,buttress material 600 can be used in conjunction with a surgical staplerwhere the surgical stapler can include anvil 602 and staple cartridge610. In such embodiments, surgical staples can be deployed from staplecartridge 610 and can be deformed by anvil 602 in order to capturebuttress material 600 against soft tissue 612 positioned between staplecartridge 610 and anvil 602. In various embodiments, buttress material600 may be releasably retained to anvil 602 and/or staple cartridge 610.More particularly, in at least one embodiment, anvil 602 can includefirst lip 604 extending therefrom which can be configured to releasablycapture buttress material 600 to anvil 602. In various embodiments,first lip 604 can fully surround the perimeter of buttress material 600,or, in other embodiments, first lip 604 can contact less than the fullperimeter of buttress material 600. In various embodiments, the term“perimeter” can include the geometric perimeter of the buttress materialand, in addition, the outer portions, edges, or areas of the buttressmaterial. In at least one embodiment, anvil 602 may further includesecond lip 606 extending therefrom which can releasably capture buttressmaterial 600 in a similar fashion as first lip 604. In at least onealternative embodiment, referring to FIG. 124, anvil 602 can include oneor more notches, or slots, 608 which can releasably retain buttressmaterial 600 to anvil 602. In various embodiments, notches, or slots,608 can be used in conjunction with first lip 602 and/or second lip 604,for example.

In various embodiments, as outlined above, anvil 602 and staplecartridge 610 can comprise jaw members which can be configured to applya compressive force, or pressure, to soft tissue 612 capturedtherebetween. Staple cartridge 610, referring to FIG. 125, can include aplurality of staples 614 situated therein where each staple 614 caninclude at least one deformable member having an end 616. In at leastone embodiment, buttress material 600 can include apertures 620 thereinwhere apertures 620 can be configured to receive staple ends 616 suchthat the deformable members of staples 614 can move, or slide, relativeto buttress material 600. In alternative embodiments, staple ends 616can be configured to pierce buttress material 600 to create aperturestherein. In either event, staples 614 can be deployed toward anvil 602such that staple ends 610 can contact anvil pockets 618 in anvil 602 andthe deformable members of staples 614 can be bent as illustrated in FIG.126. In at least one embodiment, as a result, the deformable members cancontact buttress material 600 and apply a force thereto to dislodgebuttress material 600 from anvil 602. Stated another way, the deformablemembers can extend through buttress material 600 in a first directionand contact buttress material 600 in a second direction after beingdeformed by anvil 602. In at least one embodiment, buttress material 600may not be immediately released from anvil 602 after the deformablemembers have been deformed. In such embodiments, referring to FIG. 127,buttress material 600 can be released from anvil 602 when anvil 602 ismoved into its open position.

In various embodiments, as outlined above, buttress material 600 maystrengthen or stiffen the soft tissue 612. More particularly, in atleast one embodiment, buttress material 600 can increase the modulus ofelasticity of the soft tissue after it has been affixed to thereto. Invarious embodiments, the buttress material can distribute thecompressive load of the staples over a larger area thereby reducing thestress created within the soft tissue. In at least one embodiment,buttress material 600, for example, can prevent, or at least inhibit,the soft tissue from entering into anvil pockets 618. More particularly,when anvil 602 is closed onto the soft tissue and a compressive pressureis applied thereto, the soft tissue may flow into anvil pockets 618 toreduce this pressure and thereby affect the ability of the staples toproperly engage and retain the soft tissue. When buttress material 600is used, however, buttress material 600 can be configured to block, orat least substantially block, the soft tissue from entering into anvilpockets 618. In various embodiments, buttress material 600 can becomprised of an absorbable, biofragmentable, or dissolvable material,much like the materials that can be used to form crowns 310 and bridges340 described above. In at least one embodiment, buttress material 600can include a therapeutic material that can be released to aid inhealing, as discussed above. In various embodiments, a flexible, rigidor semi-rigid substance can be used to create buttress material 600.

Various embodiments of the present invention are directed to surgicalprocedures using an endocutter 30 (see FIG. 1) where, for at least partof the procedure, end effector 36 of endocutter 30 is loaded with staplecartridge 64 (see FIG. 3) having staples with an integratedcrown-driver. Further, the integrated crown-driver may include recesses,such as recesses 144 shown in FIGS. 5-9, for turning the ends of thestaples. Such a staple cartridge 64 could be used in a Roux-en-Y gastricbypass procedure. In such a procedure, with reference to FIG. 128, thestomach is made smaller by creating small pouch 10 at the top of stomach12 where small stomach pouch 10 can be connected directly to the middleportion of the small intestine (jejunum) 14, thereby bypassing the restof stomach 16 and the upper portion of small intestine (duodenum) 18. Asshown in FIG. 128, adjustable band 20 is sometimes placed around thestomach pouch 10 to control the expansion of pouch 10. The pressureexerted by band 20 on stomach pouch 10 can be controlled by port 22 incommunication with band 20. With reference to FIGS. 1 and 3, endocutter30 used in the procedure could be loaded with a staple cartridge 64having staples with integrated crown-drivers, with or without thestaple-end-turning recesses 144, for the cut near where gastric band 20is to be placed. This way, the exterior surfaces of the tissue and/orthe band 20 will be protected from the ends of the staples, therebyreducing the chance that the staple ends cut or snag or otherwise damageband 20, and reducing the chance that band 20 aggravates the staples.

In various embodiments, the clinician may use one endocutter 30 in theprocedure. Endocutter 30 may be loaded with a staple cartridge havingconventional staples, such as described in U.S. Pat. No. 5,465,895, forthe cuts that will not be in the area of band 20, such as the areas 820,821 in FIG. 128. For the cut or cuts that will be in area 822 of band20, endocutter 30 can be loaded with a staple cartridge having stapleswith integrated crowns-drivers. In another embodiment, the clinician mayuse two (or more) separate endocutters 30 in the procedure. Oneendocutter 30 could be used for the cuts in the areas 820, 821 that willnot be near band 20, and the other endocutter 30, loaded with a staplecartridge having staples with integrated crowns-drivers for the cut(s)in area 822 that will be in the area of band 20.

FIG. 129 is a flow chart of the process according to variousembodiments. At step 830, the clinician uses an endocutter 30 having aconventional staple cartridge for the cut(s) for area 820 (see FIG.128). In various embodiments, of course, a different conventional staplecartridge will need to be used for each cut in area 820. Once theclinician nears area 822 where band 20 is to be placed, at step 832, theendocutter 30 may be loaded with a staple cartridge having staples withintegrated crowns-drivers. The clinician may then, at step 834, make thenecessary cut or cuts for area 822. Of course, if more than one cut isneeded in area 822, for each such cut the endocutter 30 may be loadedwith a staple cartridge having staples with integrated crowns-drivers.Once the clinician is past the area where the band 20 is to be placed,at step 836, the endocutter 30 may be loaded with a conventional staplecartridge for each additionally required cut (step 838) in area 821 toform pouch 10. Once pouch 10 is formed, at step 840, the middle portionof patient's small intestine (jejunum) 14 may be stitched to stomachpouch 10. Then, at step 842, gastric band 20 may be placed aroundstomach pouch 10, such that band 20 is placed in the area where thestaples with the integrated crowns-drivers were used. That way, thelikelihood of the staple ends snagging or rupturing band 20 is reduced,as is the likelihood that band 20 will aggravate the staples. Accordingto various embodiments, an endocutter 30 with a staple cartridge 64having integrated crown-drivers may be used for each cut used in formingstomach pouch 10.

Thus, according to various embodiments, the present invention isdirected to a process for performing a Roux-en-Y gastric bypassprocedure comprising performing a plurality of cutting/fastening stepswith a stapling endocutter 30 instrument on a patient's stomach in orderto cut the stomach into two parts (e.g., pouch 10 and bypassed stomach16) and to seal, with the staples, the two parts along the cut path. Foreach cut, the endocutter 30 may be loaded with a new staple cartridge,and for at least one of the cuts, the staple cartridge comprises stapleswith integrated crowns-drivers, as described above. The middle portionof patient's small intestine (jejunum) 14 may then be stitched tostomach pouch 10, using techniques known in the art, for example. Thengastric band 20 may be placed around stomach pouch 10, such that band 20is placed in the area where the staples with the integratedcrowns-drivers were used.

FIGS. 130 and 131 are cross-sectional side views of portions of endeffector 36 according to other various embodiments of the presentinvention. In the illustrated embodiment, a number of releasable pocketelements 650 are fitted into anvil 52. In the illustrated embodiment,there is a corresponding releasable pocket element 650 for each staple652 in the staple cartridge, although in other embodiments, as describedfurther below, a different ratio of releasable pocket elements 650 tostaples may be used. The releasable pocket elements 650 may be, forexample, integrally formed, snap-fit or otherwise inserted into anvil 52prior to use of endocutter 30.

As shown in the embodiment of FIGS. 130 and 131, releasable pocketelements 650 may define pockets 654 in to which ends 656 of staples 652are driven when the endocutter 30 is fired. Upon firing, as shown inFIG. 131, ends 656 may first engage and be turned by an upper surface658 of pocket 654. Upper surface 658 of pocket 654 may turn ends 656 ofstaples 652 toward a staple-end retaining surface 660 at the lower edgeof pocket element 650. Staple-end retaining surfaces 660 may retain ortrap ends 656 of staples 652 in pockets 654.

The force of the firing operation is preferably greater than the forceholding pocket elements 650 in anvil 52, such that pocket elements 650are released or popped-out from anvil 52 upon firing, as shown in FIG.131. That way, pocket elements 650 may remain with staples 652 in tissue662 following the cutting/fastening operation, as shown in FIG. 131. Asalso can be seen in FIG. 131, pocket elements 650 may separate afterbeing released from the anvil 52 and move with the tissue 662, forexample.

Retaining surface 660 may prevent end 656 of staple 652 from protrudingout of pocket 654 and into tissue 662 being fastened by staples 652.Further, for procedures using a band around tissue that has beenstapled, such as gastric band 20 in the Roux-en-Y gastric bypassprocedure described above, (see FIG. 128) pocket elements 650 mayprevent ends 656 of staples 652 from damaging the band 20, as well asprevent the band 20 from damaging the staple line. Among other things,this may reduce the risk of infection at the site of band placement.

Retaining surfaces 660 are preferably strong enough so that ends 656 ofstaples 652 do not puncture retaining surfaces 660, and strong enough towithstand the force required to release pocket elements 650 from anvil52. Also, retaining surfaces 660 are preferably small enough that the donot inhibit the insertion of staple ends 656 into pockets 654. Accordingto various embodiments, retaining surfaces 660, like the rest of pocketelement 650, may be made of a thermoplastic material, such as VictrexPEEK plastic, for example. The thickness of retaining surfaces 660 maybe selected based on size of the staples 652 being used, and retainingsurfaces 660 may be on the order of 0.010 inches thick according tovarious embodiments.

According to various embodiments, pocket elements 650 may be made fromthe same material as crowns 664 of the staples 652. For example, theycould be both made from bioabsorbable material or non-bioabsorbablematerial. Also, either pocket elements 650 or crowns 664, or both, couldbe laced with or otherwise comprise a therapeutic agent or drug, such asa pain relieving drug or anti-bacterial agent, that can be absorbed bysurrounding tissue 662.

FIGS. 132 and 133 show another embodiment of releasable pocket elements650, where each releasable pocket element 650 in the illustratedembodiment comprises one pocket 654. As such, there may be two pocketelements 650 for each staple 652 in such an embodiment. It should benoted that in various embodiments, a number of different pocket elements650 could be disposed in anvil 52 for use at one time. For example, forone use, some of pockets elements 650 may comprise two (or more) pockets654, and some may comprise only one pocket 654. A typical staplecartridge 64 has sixty-six staples, in six rows (three for each side ofthe incision). Preferably, there would therefore be one hundred thirtytwo (132) pockets between all of pocket elements 650 placed in the anvil52—two pockets for each staple 652 (or one pocket for each staple end656).

An endocutter having anvil 52 loaded with such releasable pocketelements could also be used for cutting steps in the area where a bandis to be placed around the cut tissue, such as in a Roux-en-Y gastricbypass procedure, as described above. The clinician may use a separateendocutter 30, having anvil 52 with releasable pocket elements 650 forthe cut in the area where band 20 is to be placed, or the cliniciancould use one endocutter 30 in the procedure, where the clinician(and/or a member of his/her team) modifies anvil 52 to insert releasablepocket elements 650 for the cut where band 20 is to be placed. In yetanother embodiment, the endocutter 30 could allow for interchangeableanvils 52, where one anvil 52 does not have releasable pocket elements650 and another one does. Anvil 52 with releasable pocket elements 650could then be used for the cut in the area of band 20.

In various embodiments, the surgical staples discussed above, orincorporated herein by reference, can be used, not only with a linearstapler, but also with a circular surgical stapler. In the circularstapler embodiment, the surgical staples can have the same features,functions and compositions as discussed above. Instead of loading thestaples into a plurality of cavities in a staple cartridge having alinear configuration, however, the staples are instead loaded into aplurality of cavities in a staple cartridge having a circularconfiguration.

In various embodiments, referring to FIGS. 134-136, circular stapler 900can include head 902, anvil 904, adjustment knob assembly 906, andtrigger 908 where head 902 can be coupled to handle assembly 910 byarcuate shaft assembly 912. In at least one embodiment, trigger 908 canbe pivotally supported by handle assembly 910 and can act to operatestapler 900 when a safety mechanism (not illustrated) is released. Whentrigger 908 is activated, a firing mechanism (not shown in FIG. 134) canoperate within shaft assembly 912 so that staples 914 are expelled, ordeployed, from head 902 into forming contact with anvil 904.Simultaneously, knife 916 operably supported within head 902 can act tocut tissue clamped between head 902 and anvil 904. Stapler 900 can thenremoved from the surgical site leaving the stapled tissue in its place.

FIGS. 135 and 136 illustrate one form of anvil 904 and head 902 that maybe employed in connection with various embodiments of the subjectinvention. As can be seen in these figures, anvil 904 can includecircular body portion 920 having anvil shaft 922 for attaching a trocar(not shown) thereto. In at least one embodiment, anvil body 920 caninclude staple forming surface 924 thereon and can also include shroud926 attached to the distal end thereof. Anvil 904 may be furtherprovided with a pair of trocar retaining clips or leaf-type springs 928that can serve to releasably retain the trocar in retaining engagementwith anvil shaft 922. In various embodiments, plastic knife board 930may be fitted into cavity 932 in anvil body 904.

In various embodiments, referring to FIG. 136, head 902 may comprisecasing member 940 that supports a cartridge supporting assembly in theform of circular staple driver assembly 942 therein that is adapted tointerface with circular staple cartridge 944 and drive staples 914supported therein into forming contact with staple forming surface 924of anvil 904. In at least one embodiment, circular knife member 916 isalso centrally disposed within staple driver assembly 942. In variousembodiments, the proximal end of casing member 940 may be coupled toouter tubular shroud 946 of arcuate shaft assembly 912 by distal ferrulemember 948. More details regarding circular staples and staplers may befound in U.S. patent application Ser. No. 11/541,151, entitled SURGICALCUTTING AND STAPLING DEVICE WITH CLOSURE APPARATUS FOR LIMITING MAXIMUMTISSUE COMPRESSION FORCE, which was filed on Sep. 29, 2006, thedisclosure of which is hereby incorporated by reference herein.

When performing an anastomosis, a lumen, such as the large or smallintestine, for example, can be stapled using a circular surgical staplerwith at least two rows of staples being emplaced on either side of atarget section (i.e., specimen) of the intestine. In variousembodiments, the target section is usually simultaneously cut as thesection is stapled. Next, after removing the specimen, a surgeon caninsert the anvil into the proximal end of the lumen, proximal of thestaple line. In at least one embodiment, this is done by inserting theanvil head into an entry port cut into the proximal lumen by thesurgeon. On occasion, the anvil can be placed transanally, or eventransorally, by placing the anvil head on the distal end of the staplerand inserting the instrument through the rectum or mouth, respectively.In order to operably engage the anvil with the surgical stapler, invarious embodiments, the distal end of the stapler may be insertedtransanally, for example. The surgeon can then tie the proximal end ofthe intestine to the anvil shaft using a suture or other conventionaltying device. Next, the surgeon can cut excess tissue adjacent to thetie and the surgeon can attach the anvil to the actuation shaft of thestapler. The surgeon can then close the gap between the anvil andcartridge, thereby engaging the incised proximal and distal ends of theintestine in the gap. The surgeon may next actuate the stapler causingat least two rows of staples to be driven through the incised proximaland distal ends of the intestine thereby joining the ends of theintestine and forming a tubular pathway after the staples have beenformed. Simultaneously, as the staples are driven and formed, aconcentric circular blade, knife or cutting member may be driven throughthe intestinal tissue ends, cutting the ends adjacent to the inner rowof staples. The surgeon can then withdraw the stapler from the intestineand the anastomosis is complete.

In various embodiments, referring to FIGS. 137-139, the presentinvention is directed to surgical stapler 900 having washer 970 that isinserted in anvil 904, as shown in FIG. 137, which is an exploded viewof washer 970 and anvil 904, and FIG. 138, which shows washer 970inserted in anvil 904. In at least one embodiment, washer 904 may bepressure or snap fit into the opening of anvil 904 such that washer 904is retained in place during the procedure. As can be seen in FIG. 139,washer 904 may include inner portion 972 and outer portion 974. Outerportion 974 may include inner row 976 and outer row 978 of staple guidesections. In various embodiments, each staple guide section 976, 978 mayinclude holes 979 through which the ends of the inner and outer rows ofstaples 914, respectively, may be driven when circular stapler 900 isfired. The ends of the staples, after being driven through opening 979,may be turned, or deformed, by staple forming pockets 901 of anvil 904.Once turned by anvil 904, the end of staples 914 may contact stapleguide sections 976, 978, thereby preventing the end of staples 914 fromprotruding into the tissue being severed/stapled. Also as can be seen inFIG. 139, outer portion 974 of washer 970 may have spring sections 980between the staple guide sections of inner row 976 and outer row 978. Inat least one embodiment, spring sections 980 may provide a discreteamount of flexibility relative to the nominal diameter of ring 972. Inaddition, inner staple guide sections 976 can be connected to innerportion 972 of the washer by tabs 982.

In various embodiments, washer 970, including inner portion 972 andouter portion 974, may be integrated together, being made from moldedplastic. For reasons that will be apparent below, washer 970 can be madefrom a non-absorbable material, such as PEEK brand thermoplastic,although, in other embodiments, at least a portion of washer 970 couldbe made from a plastic material that is absorbable. In use, when fired,knife 916 may cut tabs 982, thereby causing outer portion 974 of washer970 to break off from inner portion 972 of washer 970 at tabs 982, suchthat inner portion 972 can remain inside anvil 904 after thecutting/stapling step, but outer portion 974 can remain with the staplesand the tissue after stapler 900 is removed. Having such a ring-typewasher portion 972 that remains with the staples and tissue after aprocedure may have several benefits. For example, for patients havingoperations which reduce the size of their stomach, such as Roux-en-Ygastric bypass surgery, ring-type washer portion 972 may preventdilation of the gastrojejunal anastomosis by providing a fixed sizestaple line, i.e., fixed by the dimensions of ring-type washer portion972. Fixing the size of the gastrojejunal anastomosis may preventdilation of the stoma, thereby potentially allowing the patient toexperience long-term weight reduction.

According to other embodiments, spring sections 980 may be formed froman elastic material that may be overmolded onto ring 972. Also, althoughring 972 is shown in the figures as being generally circular, it shouldbe recognized that ring 972 may assume other shapes, such as elliptical,for example. In a bowel anastomosis, elliptical ring 972 may potentiallyprovide a larger lumen than a circular ring. Further, if anon-absorbable material is used for ring 972, the lumen could be held ina constant size and form.

In addition, in various embodiments, ring 972 may be laced with orotherwise comprise a healing agent that, when in contact with tissuewould enhance the healing of the tissue within the anastomotic site.Additionally, ring 972 may include or otherwise comprise a remotelydetectable material that allows the position and orientation of ring 972to be sensed in the patient at some later point in time. For example,ring 972 could be made from a material that is opaque to certainfrequencies of radio waves or otherwise detectable by electromagneticradiation. That way, the position and orientation of ring 972 at theanastomotic site may be identifiable using an x-ray machine, forexample. In other embodiments, ring 972 may be made from a materialhaving or otherwise comprise fluorescent nanoparticles that can bedetected using a fluoroscopy device. The nanoparticles may be, forexample, inorganic nanoparticles, like a semiconductor nanocrystals,silica-based nanoparticles such as those described in U.S. patentapplication Ser. No. 10/536,569, entitled FLUORESCENT SILICA-BASEDNANOPARTICLES, filed on Nov. 26, 2003, U.S. patent application Ser. No.11/119,969, entitled PHOTOLUMINESCENT SILICA-BASED SENSORS AND METHODSOF USE, filed on May 2, 2005, and U.S. patent application Ser. No.10/306,614, entitled FLUORESCENT SILICA-BASED NANOPARTICLES, filed onNov. 26, 2002, the disclosures of which are hereby incorporated byreference herein, or any other inorganic particle capable of attachingto or containing a fluorescence material. The nanoparticles may also beorganic nanoparticles, like liposomal spheres, dimer structures, orother organic structures capable of attaching to or containing afluorescence material.

In yet other embodiments, staple forming pockets 901 of anvil 904, maybe integrated with ring 972. As such, ring 972 would include a pocket(not shown) for each staple leg opening 979, extending distally from theplane of ring 972, such that the staple legs would be turned by thepocket back on ring 972. In such an embodiment, the pockets in anvil 904could be eliminated.

In various embodiments, referring to FIGS. 140-148, circular surgicalstapler 700 can include staple cartridge mechanism 702, elongate shaft704, and anvil member 706. In at least one embodiment, staple cartridgemechanism 702 can be removably attached to surgical stapler 700 suchthat, after the staples in a first staple cartridge mechanism 702 havebeen deployed, the first staple cartridge mechanism 702 can be removedand can be replaced with a second staple cartridge mechanism 702, forexample. In various embodiments, referring to FIGS. 141 and 144, staplecartridge mechanism 702 can include staple cartridge portion 716 andactuation shaft 714 extending therefrom. In at least one embodiment,referring to FIGS. 140-142, actuation shaft 714 can be configured toextend through aperture 712 in anvil member 706. In such embodiments,surgical stapler 700 can further include an actuation mechanism (notillustrated in FIGS. 140-148) which can be configured to motivateactuation shaft 714 and thereby move staple cartridge mechanism 702relative to anvil member 706. In at least one embodiment, aperture 712can be positioned at the distal end of the actuation mechanism and canbe configured to receive actuation shaft 714 in a snap-fit and/orpress-fit arrangement. In various embodiments, although not illustrated,at least one of actuation shaft 714 and the actuation mechanism caninclude a detent mechanism which can releasably retain actuation shaft714 to the actuation mechanism.

In various embodiments, when actuation shaft 714 is engaged in aperture712, as described above, or is otherwise operably engaged with theactuation mechanism, the actuation mechanism can control the distancebetween anvil member 706 and staple cartridge mechanism 702. In at leastone embodiment, in order to deploy staples removably stored withinstaple cartridge 716, a surgeon, or clinician, can actuate the actuationmechanism in order to pull actuation shaft 714 toward anvil member 706and thereby cause the staples to contact anvil member 706 and securesoft tissue therein, as described above. In various embodiments, staplecartridge mechanism 702 can further include a staple driver (notillustrated) operably engaged with actuation shaft 714 such that, whenactuation shaft 714 is pulled by the actuation mechanism, actuationshaft 714 can move the staple driver relative to staple cartridgeportion 716 and deploy the staples therefrom. In either event, actuationshaft 714 can then be disengaged from the actuation mechanism and thespent staple cartridge mechanism 702 can be removed. In suchembodiments, the remainder of surgical stapler 700 can be left in thesurgical site while a new staple cartridge mechanism 172, for example,is attached thereto. Such embodiments are an improvement over previoussurgical devices which required the surgeon to remove the entiresurgical instrument from the surgical site to reload a new staplecartridge. In various embodiments, the time to complete a particularsurgery can be reduced and, in various circumstances, the surgery can beless invasive to the patient.

In various alternative embodiments, referring to FIGS. 146 and 147,staple cartridge portion 716 of staple cartridge mechanism 702 can bedetached from actuation shaft 714. In such embodiments, actuation shaft714 can remain operably engaged with the actuation mechanism while thespent staple cartridge portion 716 is replaced. In either event, invarious embodiments, knife, or cutting member, 718 can be mounted oneither anvil member 706 (FIG. 140) or on staple cartridge mechanism 702(FIG. 144). When cutting member 718 is mounted on anvil member 706,referring to FIG. 140, knife 718 can be mounted inboard of the pluralityof anvil pockets 710 and may be moveable in an axial direction toward oraway from staple cartridge mechanism 702. When mounted on staplecartridge mechanism 702, referring to FIG. 144, knife 718 can be mountedinboard of staple cartridge 716 and can be moveable in an axialdirection towards or away from anvil member 706. In at least one variousembodiment, cutting member 718 can rotate when it is moved axially asdescribed above and can be configured to trim portions of the intestinenear the staple line.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device canutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present application.

Preferably, the invention described herein will be processed beforesurgery. First, a new or used instrument is obtained and if necessarycleaned. The instrument can then be sterilized. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK bag. The container and instrument are thenplaced in a field of radiation that can penetrate the container, such asgamma radiation, x-rays, or high-energy electrons. The radiation killsbacteria on the instrument and in the container. The sterilizedinstrument can then be stored in the sterile container. The sealedcontainer keeps the instrument sterile until it is opened in the medicalfacility.

While this invention has been described as having exemplary designs, thepresent invention may be further modified within the spirit and scope ofthe disclosure. This application is therefore intended to cover anyvariations, uses, or adaptations of the invention using its generalprinciples. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this invention pertains.

1. A staple cartridge assembly for use with a surgical stapler, saidstaple cartridge assembly comprising: a staple cartridge bodycomprising: a first side; a second side; a top surface; and a pluralityof staple cavities comprising a first group of staple cavities definedin said first side and a second group of staple cavities defined in saidsecond side, wherein each staple cavity comprises an opening extendingthrough said top surface, and wherein said plurality of staple cavitiesare arranged in a plurality of rows; and a plurality of staplespositionable within said staple cavities, wherein each said staplecomprises: a base comprised of a first material; a first deformablemember extending from said base, wherein at least a portion of saidfirst deformable member is comprised of an expandable material; and acrown at least partially surrounding said base, wherein said crown iscomprised of a bioabsorbable material that is different from said firstmaterial.
 2. The staple cartridge assembly of claim 1, furthercomprising a driver, wherein said driver comprises at least one inclinedsurface configured to engage said staples and eject said staples fromsaid staple cavities.
 3. The staple cartridge assembly of claim 2,further comprising a cutting member, wherein said staple cartridge bodyfurther comprises a longitudinal slot configured to receive said cuttingmember.
 4. The staple cartridge assembly of claim 3, further comprisinga firing member configured to motivate said driver and said cuttingmember.
 5. The staple cartridge assembly of claim 3, wherein said firstgroup of said staple cavities are arranged in two rows of staplecavities and said second group of staple cavities are arranged in tworows of staple cavities.
 6. The staple cartridge assembly of claim 5,wherein said rows of staple cavities are substantially parallel.
 7. Thestaple cartridge assembly of claim 1, wherein said crown is comprised ofa plastic material overmolded onto said base.
 8. The staple cartridgeassembly of claim 1, wherein said staples each comprise a seconddeformable member extending from said base, wherein said crown connectssaid first deformable member and said second deformable member beforesaid crown has been absorbed, and wherein said first deformable memberis unconnected to said second deformable member after said crown hasbeen absorbed.
 9. The staple cartridge assembly of claim 1, wherein atleast a portion of said first deformable member is comprised of abioabsorbable material.
 10. The staple cartridge assembly of claim 1,wherein said staples each comprise a second deformable member extendingfrom said base and wherein at least a portion of said second deformablemember is comprised of an expandable material.
 11. The staple cartridgeassembly of claim 1, wherein said expandable material includes abioabsorbable material.
 12. The staple cartridge assembly of claim 1,wherein said portion of said first deformable member is expandablebetween a first diameter and a second diameter.
 13. The staple cartridgeassembly of claim 1, wherein at least a portion of said crown iscomprised of an expandable material.
 14. The staple cartridge assemblyof claim 1, wherein said first deformable member further comprises anend configured to pierce soft tissue and create a hole therein, andwherein said portion of said first deformable member is configured toexpand within said hole.
 15. The staple cartridge assembly of claim 1,wherein said expandable material comprises a hydrophilic material. 16.The staple cartridge assembly of claim 1, further comprising a pluralityof bridges, wherein each said bridge connects at least two adjacentstaples in said plurality of staples.
 17. The staple cartridge assemblyof claim 16, wherein said bridges are comprised of said bioabsorbablematerial.
 18. The staple cartridge assembly of claim 1, wherein at leasta portion of said first deformable member comprises a non-circularcross-section.
 19. The staple cartridge assembly of claim 1, furthercomprising an anvil, wherein said anvil is configured to deform saidfirst and second deformable members when said staples are ejected fromsaid staple cavities.
 20. A staple cartridge assembly for use with asurgical stapler, said surgical stapler comprising a slidable cuttingmember, said staple cartridge assembly comprising: a staple cartridgebody comprising: a first end; a second end; a first side; a second side;a slot extending between said first side and said second side, whereinsaid slot is configured to receive the cutting member; a top surface;and a plurality of staple cavities comprising a first row of staplecavities defined in said first side and a second row of staple cavitiesdefined in said second side, wherein each staple cavity comprises anopening extending through said top surface, and wherein said pluralityof staple cavities are arranged in a plurality of rows; a plurality ofstaples positionable within said staple cavities, wherein each saidstaple comprises: a base comprised of a first material; a firstdeformable member extending from said base, wherein at least a portionof said first deformable member is comprised of an expandable material;and a crown at least partially surrounding said base, wherein said crownis comprised of a bioabsorbable material that is different from saidfirst material; and a sled movable between said first end and saidsecond end to eject said staples from said staple cavities.
 21. Thestaple cartridge assembly of claim 20, wherein each said crown comprisesa drive surface, and wherein said sled is configured to contact saiddrive surfaces.
 22. A staple cartridge assembly for use with a surgicalstapler, said staple cartridge assembly comprising: a staple cartridgebody comprising: a first end; a second end; a first side; a second side;a slot extending between said first side and said second side, whereinsaid slot is configured to receive a cutting member; a top surface; anda plurality of staple cavities comprising a first row of staple cavitiesdefined in said first side and a second row of staple cavities definedin said second side, wherein each staple cavity comprises an openingextending through said top surface, and wherein said plurality of staplecavities are arranged in a plurality of rows; a plurality of staplespositionable within said staple cavities, wherein each said staplecomprises: a base comprised of a first material; a first deformablemember extending from said base, wherein at least a portion of saidfirst deformable member is comprised of an expandable material; and acrown at least partially surrounding said base, wherein said crown iscomprised of a bioabsorbable material that is different from said firstmaterial, wherein said crown comprises a tissue-contacting surface and adrive surface, and wherein said base is positioned between saidcompression surface and said drive surface; and a sled movable betweensaid first end and said second end to eject said staples from saidstaple cavities.